cambodia study design 20131030 - actwatch...! 4! figure!1:!map!of!cambodia!!!!! source:!,!2013!...

67
ACTwatch 2013 Outlet Survey Study Design – Cambodia

Upload: others

Post on 05-Jul-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

!

!

ACTwatch!2013!Outlet!Survey!

Study!Design!–!Cambodia!

!

Page 2: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

!

Investigators!and!Institutional!Affiliations!!

!

Principal!Research!Investigators!!

Dr.!Vamsi!Vasireddy!Principal!Investigator,!ACTwatch!Population!Services!International!!

Henrietta!Allen!Malaria!Technical!Advisor!PSI!Cambodia!!CoEInvestigators!!

!

Dr.!Lek!Dysoley!Deputy!Director!of!Technical!Bureau!Cambodia!National!Center!for!Parasitology,!Entomology!and!Malaria!Control!!

Dr.!Siv!Sovannaroth!Chief!of!Technical!Bureau!Cambodia!National!Center!for!Parasitology,!Entomology!and!Malaria!Conrol!!

Sochea!Phok!ACTwatch!Cambodia!Country!Program!Coordinator!PSI!Cambodia!!

Ms.!Phou!Mean!Research!Coordinator!PSI!Cambodia!!

Stephen!Poyer!ACTwatch!Deputy!Principal!Investigator!Population!Services!International!!

Dr.!John!Rogers!ACTwatch!Research!Manager!Population!Services!International!!

Kevin!Duff!ACTwatch!Research!Associate!Population!Services!International!

PSI!Cambodia!

No.!29,!334!Street!Boeung!Keng!Kang!1!Khan!Chamcar!Mon!Phnom!Penh,!Cambodia!Phone:!+!855T23T210!814/987!404!Fax:!+!855T23T218T735!!

ACTwatch!

Population!Services!International!Whitefield!Place,!School!Lane,!PO!Box!14355T00800,!Westlands!Nairobi,!Kenya!!Phone:!254T020T444T0125!!

Page 3: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

!

Table!of!Contents!

List!of!Figures!and!Tables!..................................................................................................!1!

List!of!Abbreviations!.........................................................................................................!2!

1.0.!Background!................................................................................................................!3!! 1.1.! ACTwatch!Research!Project!..........................................................................!3!! 1.2.! Overview!of!the!Country!..............................................................................!3!! 1.3.! Description!of!the!Health!Care!System!.........................................................!4!! 1.4.! Malaria!Epidemiology!...................................................................................!5!! 1.5.! Malaria!Diagnosis!and!Treatment!Guidelines!...............................................!6!! 1.6.! Malaria!Control!Strategy!..............................................................................!7!! 1.7.! Malaria!Treatment!in!the!Public!and!Private!Sectors!...................................!9!

2.0.!Methodology...............................................................................................................!10! !! 2.1.! General!Study!Design!....................................................................................!10!! ! 2.1.1.! Sampling!Frame!and!Stratification!....................................................!10!! ! 2.1.2.! Questionnaires!..................................................................................!10!! ! 2.1.3.! Adaptation!of!Questionnaires!...........................................................!11!! 2.2.! Indicators!......................................................................................................!12!! 2.3.! Sampling!Outlets!...........................................................................................!13!! ! 2.3.1.! Selection!Procedures!for!the!Communes!.........................................!13!! ! 2.3.2.! Selection!Procedures!for!the!Booster!Sample!..................................!13!! ! 2.3.3.! Identification!of!Outlets.....................................................................!14!! 2.4.! Sample!Size!...................................................................................................!15!! ! 2.4.1.! Required!Number!of!Outlets!.............................................................!16!! ! 2.4.2.! Required!Number!of!Outlets!to!be!Enumerated!..............................!17!! ! 2.4.3.! Required!Number!of!Clusters!...........................................................!17!! ! 2.4.4.! Predicted!Number!of!Outlets!and!ACTs.............................................!18!! 2.5.! Sampling!Procedures!....................................................................................!19!

3.0.!Research!Team!...........................................................................................................!21! !

4.0.!Quality!Control!Measures!..........................................................................................!21! !

5.0.!Training!.......................................................................................................................!22! !

6.0.!Data!Management!.....................................................................................................!22! !

7.0.!Analysis!Plan!..............................................................................................................!22! !

8.0.!Ethical!Issues!..............................................................................................................!23! !

9.0.!Communication!and!Dissemination!..........................................................................!24!

Page 4: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

!

Annex!1.!List!of!Global!Fund!Quality!Assurance!Policy!ACTs............................................!25! !

Annex!2.!2013!Outlet!Survey!Activities!and!Schedule......................................................!26!

Annex!3.!Outlet!Survey!Questionnaire!.............................................................................!28! !

Annex!4.!Key!Informant!Interview!Guide!.........................................................................!49!

Annex!5.!Selected!Communes...........................................................................................!51!

Annex!6.!Definitions!of!Outlet!Types!................................................................................!54! !

Annex!7.!Outlet!Survey!Information!Sheet!and!Guide!....................................................!56! !

Annex!8.!Key!Informant!Interview!Information!Sheet!and!Guide!...................................!59!

!

References!.........................................................................................................................!62

Page 5: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 1!

List!of!Figures!and!Tables!

!

Figures!

Figure!1.!Map!of!Cambodia!...............................................................................................!4!

Figure!2.!Artemisinin!Tolerance!Zone!Designation!..........................................................!6!

!

Tables!

Table!1.!Administrative!levels!in!Cambodia......................................................................!10!

Table!2.!ACTwatch!Indicators!...........................................................................................!12!

Table!3.!Predicted!Number!of!Outlet!Types!to!Visit!and!ACTs!to!Audit!by!Domain!.......!18!!

! !

Page 6: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 2!

List!of!Abbreviations!

!

ACT! ArtemisininTbased!Combination!Therapy!AETD! Adult!Equivalent!Treatment!Dose!A+M! Artesunate!+!Mefloquine!CNM! National!Centre!for!Entomology,!Parasitology!and!Malaria!Control!DDF! Department!of!Drugs!and!Food!DHAEPIP! Dihydroartemisinin!PiperaquineGDP! Gross!Domestic!Product!GPS! Global!Positioning!System!IMCI! Integrated!Management!of!Child!Illness!KII! Key!Informant!Interview!LSHTM!! London!School!of!Hygiene!and!Tropical!Medicine!MOH! Ministry!of!Health!ORS! Oral!Rehydration!Salts!Pf! Plasmodium!falciparum!Pv! Plasmodium!vivax!Pm% Plamodium!malariae!PQ! Primaquine!PI! Principal!Investigator!PPS! Probability!Proportional!to!Population!Size!PSI! Population!Services!International!QAACT! QualityTassured!ACT!RDT! Rapid!Diagnostic!Test!for!Malaria!SP! Sulfadoxine!Pyrimethamine!VMW! Village!Malaria!Worker!! %! !

Page 7: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 3!

1.!Background!

1.1.!ACTwatch!Research!Project!

In!2008,!Population!Services! International! (PSI)! in!partnership!with! the! London!School!of!Hygiene!and!Tropical!Medicine! (LSHTM)! launched!a!multiTcountry! research!project!called!ACTwatch.!The!project!is!designed!to!provide!a!comprehensive!picture!of!the!antimalarial!market!to!inform!the!evolution!of!national!and!international!antimalarial!drug!policy.!The!research!is!designed!to!detect!changes!in!the!availability,!price!and!use!of!antimalarials!and!rapid!diagnostic!tests!(RDTs)!over!time!and!between!sectors,!and!to!monitor!the!effects!of!policy!or! intervention!developments!at! the!country! level.!Starting! in!2013,!ACTwatch!will!also!be!collecting!information!on!the!availability!of!oral!rehydration!salts!(ORS)!and!zinc.!

ACTwatch!addresses!both! the! supply! and!demand! side!of! the!market.! The! supply! side! is!evaluated!by!collecting!level!and!trend!data!on!antimalarials!and!RDTs!in!public!and!private!sector! outlets.! To! evaluate! demand,! client! exit! interviews! will! be! conducted! at! health!facilities!to!determine!consumer!treatmentTseeking!behavior!and!knowledge.!Findings!can!help!determine!where! and! to!what! extent! interventions!may!positively! impact! access! to!and!use!of!qualityTassured!artemisinin!combination!therapies!(QAACTs)!and!RDTs!as!well!as!resistance!containment!efforts.!

The!project!is!being!conducted!in!nine!malariaTendemic!countries:!Benin,!Cambodia,!DRC,!Kenya*,!Madagascar,!Nigeria,! Tanzania*,!Uganda!and!Zambia!between!2013!and!2015.! In!addition,! ACTwatch! staff! provide! technical! assistance! supplyTside! research! studies! in!Myanmar.! Countries!were! selected!with! the! aim! of! studying! a! diverse! range! of!markets!from!which!comparisons!and!contrasts!could!be!made.!Two!outlet!surveys!are!planned!for!Cambodia,!the!first!in!2013!and!the!second!in!2015.!

1.2.!Overview!of!the!Country!

Cambodia!is!located!in!SouthTEast!Asia!and!borders!Thailand,!Vietnam!and!Laos!(Figure!1).!!It! has! a! population! of! 15.2! million,! predominantly! rural1.! In! 2012,! the! gross! domestic!product! (GDP)! per! capita!was!US$2,400! and!20%!of! the!population!was! living!under! the!poverty!line2.!Most!of!the!employed!labor!force!works!in!private!local!enterprises!on!their!own!account!or!as!unpaid!family!workers,!indicating!the!importance!of!the!informal!sector.!The! agriculture,! forestry! and! fishing! sectors! include! 72%! of! the! employed! population,!however,! due! to! a! narrow! focus! on! paddy!production,! account! for! only! 32%!of!GDP.! By!contrast,! the! wholesale! and! retail! trade! sector! which! accounts! for! 8%! of! the! employed!population!contributes!nearly!39%!of!GDP3.!

! !

* At the time of writing, research in Kenya and Tanzania is pending funding.

Page 8: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 4!

Figure!1:!Map!of!Cambodia!

!

!

!

!

!

!

!

!

! Source:!www.worldtravels.com,!2013!

The! importance!of!the!private!commercial!sector! is!relatively!recent.!From!1975!to!1979,!the!Khmer!Rouge!regime! implemented!a! form!of!agrarian!socialism,!characterized!by!the!abolition! of! money! and! private! property,! and! after! the! fall! of! the! regime,! a! socialist!economic!model!was! implemented.! In!1993,! the!UNTsupervised! first!election!marked! the!start! of! progress! towards! recovery! and! from! 1998,! after! a! second! round! of! elections,!economic! and! political! stability! returned.! Several! reforms! were! then! implemented,!including!market! liberalization,!complete!dollarization!of!the!economy!and!administrative!decentralization4.!

1.3.!Description!of!the!Health!Care!System!

Cambodia!has!also!engaged! in! significant! reforms! in! the!health! sector! including!a!Health!Coverage! Plan! designed! to! improve! primary! health! care! coverage;! the! allocation! of!financial! resources! to! provincial! health! departments;! and! the! creation! of! operational!districts!and!the!establishment!of!communityTbased!programs,!notably!for! immunizations!and!birth! spacing.!However,!Cambodia!has!a!persistently!high!maternal!mortality! rate!of!206! deaths! per! 100,000! pregnancies,! and! an! underTfive!mortality! rate! of! 54! deaths! per!1,000!live!births5.!The!public!health!system!continues!to!face!major!challenges,!especially!in!terms!of!growing!inequities,!with!relatively!poor!access!to!public!health!services,!especially!amongst!the!poor4,6.!

Around! 80%! of! care! seeking! visits! are! to! the! private! sector5,! where! a! wide! range! of!providers!operate,!including!pharmacists,!mobile!providers,!drug!shopkeepers!and!grocery!sellers,! but! also! at! times! government! doctors! and! nurses! running! their! own! private!practices.!Many!providers!however!operate!with!limited!or!no!health!qualifications!but!are!

Page 9: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 5!

widely!used,!especially!by!poorer!groups7!and!in!remote!forested!areas!where!communities!have!no!access!to!formal!health!services8.!

The! pharmaceutical! sector! is! regulated! by! the! 2007! Pharmaceutical! Law.! Regulation! is!overseen!and! implemented!by! the!Department!of!Drugs!&!Food! (DDF)!of! the!Ministry!of!Health! (MOH),! in! collaboration! with! municipal! (Phnom! Penh)! and! provincial! health!departments!to!which!some!tasks!have!been!delegated.!The!importation!of!pharmaceutical!products!is!regulated!by!the!DDF!and!importers!are!required!to!be!staffed!by!a!pharmacist!and! to! obtain! an! import! permit! before! each! drug! shipment.! Sales! of! pharmaceutical!products!to!endTusers!are!regulated!by!provincial!health!departments!and!3!categories!of!licenses!are!available:!1)!pharmacy!licenses!for!outlets!managed!by!a!pharmacist,!2)!depot!A! licenses! for! outlets! managed! by! an! assistant! pharmacist,! and! 3)! depot! B! licenses! for!outlets! managed! by! a! nurse/midwife.! Pharmacy! license! holders! are! authorized! to!wholesale!pharmaceutical!drugs!and!all!license!holders!may!open!one!outlet!only,!implying!that! integrated! chains! of! drug! outlets! are! not! authorized.! Registered! drug! outlets! are!permitted! to! sell! registered! pharmaceutical! drugs,! hygienic! and! cosmetic! products! with!preventive! and! curative! properties,! and! dental,! laboratory! and! medical! equipment.! The!sale!of!other!consumer!goods,!such!as!household!products!or!food!is!forbidden.!Prices!and!markTups!on!pharmaceutical!products!are!not!regulated!and!a!substantial!number!of!illegal!pharmaceutical! outlets! continue! to! operate! despite! tighter! regulatory! measures!implemented!by!the!MOH9.!

1.4.!Malaria!Epidemiology!

In! Cambodia,! malaria! is! transmitted! by! Anopheles! dirus,! minimus! and! sundaicus!mosquitoes!breeding!in!forests!and!jungles!covering!60%!of!the!landmass10.!Malaria!is!not!endemic!across!the!country.!Parasite!prevalence!rates!are!reported!to!reach!15%!to!40%!in!remote! forested! areas! compared! to! 0%! to! 3%! in! the! plains11.! An! estimated! 44%! of! the!population,!or!approximately!6.3!million!people!live!in!high!transmission!areas10.!Adult!men!experience!the!highest!malaria!prevalence!rates,!reflecting!the!increased!occupational!risk!associated!with!forest!goers12.!Malaria!transmission!risk!is!seasonal!and!associated!with!the!rainy! season,!with! peaks! generally! around!August/September.! Around!63%!of! confirmed!cases!are!Plasmodium!falciparum!(Pf)!and!37%!Plasmodium!vivax!(Pv)!malaria10.!

Cambodia! has! seen! a! general! decline! in! clinically! diagnosed! cases! of! malaria! and! case!fatality!over! the!past!decade13,! coupled!with!a! significant! and! steady!decrease! in!overall!malaria! prevalence! measured! with! blood! slides! from! 4.4%! in! 2004! to! 0.9%! in! 201012.!Malaria!remains!a! leading!cause!of!morbidity!and!mortality! in!the!country.!Accordingly,!a!diverse! range! of! interventions! have! been! undertaken! with! the! goal! of! achieving! preTelimination! of!malaria! across! Cambodia! by! 2015! and! phased! elimination! of! all! forms! of!malaria!in!Cambodia!by!202513.!

Given! the! emergence! of! artemisininTresistant! parasites,! the! National! Centre! for!Entomology,!Parasitology!and!Malaria!Control!(CNM)!has!delineated!areas!with!confirmed!

Page 10: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 6!

multiTdrug!resistant!parasites.!With!this!strategy,!the!country’s!malaria!endemic!area!was!classified!into!three!zones:!1)!areas!where!artemisinin!tolerance!has!been!detected!(this!is!also!a!targeted!area!for!elimination),!2)!areas!with!no!evidence!of!tolerance!but!considered!at!risk!(known!as!a!‘buffer’!area)!and!3)!the!remaining!malaria!endemic!provinces.!In!2010,!the!zones!were!further!revised! into!four!areas,!referred!to!as!zone!1,!zone!2,!zone!3!and!"no!zone".!Under!the!new!mapping!some!areas!previously!demarcated!as!zone!2!now!fall!into!zone!1.!The!largest!difference!is!the!new!demarcation!of!"no!zone".!No!zone!and!zone!3!areas!are!not!at!risk!of!artemisinin!tolerance!and!are!both!malaria!endemic,!however,!no!zone! areas! have!much! lower!malaria! prevalence! compared! to! prevalence! in! zone! 3.! No!zone!areas!largely!comprise!former!zone!2!and!zone!3!areas.!No!zone!areas!buffer!zone!2!areas! in! western! Cambodia! and! around! the! Tonle! Sap! Lake.! Figure! 2! illustrates! these!divisions!by!commune.!

Figure!2.!Cambodia!Artemisinin!Tolerance!Zone!Designation!

!

!!!!!!!!!!

!!!!!!

! !!!!!! !Source:!CNM,!2011!

1.5.!Malaria!Diagnosis!and!Treatment!Guidelines!

To! manage! and! prevent! the! burden! of! malaria! and! multiTdrug! resistance,! the! MOH!introduced!treatment!guidelines!in!2004!and!simultaneously!educated!providers!on!correct!malaria! treatment.! Diagnosis,! treatment! of! uncomplicated! and! severe!malaria! in! adults,!management! of! malaria! in! children,! management! of! malaria! in! pregnancy! and!recommendations!for!temporary!travelers!to!malaria!endemic!areas!were! included!in!the!treatment! guidelines.!Updated!malaria! treatment! guidelines!were! produced! in! 2007! and!2011!in!accordance!with!local!needs!and!the!antimalarial!drug!sensitivity!profiles.!The!most!recent!guidelines!provide!updated!information!on!firstT!and!secondTline!treatments!and!the!care!of!children!and!pregnant!women!with!malaria.!

Page 11: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 7!

To! treat! uncomplicated! malaria! in! adults! the! 2011! guidelines! recommend! the! use! of!dihydroartemisininTpiperquine! (DHATPIP)! +! primaquine! (PQ)! or! artesunate! +! mefloquine!(A+M)! +! PQ! as! the! firstTline! treatment! for! Pf,! Pv! or! Pm! malaria.! To! adapt! the!recommendation! to! the! Cambodian! population,! specific! A+M! brands! for! the! referral!hospitals,! health! centers! and! health! posts! are! preTpackaged! with! age! specific! dosing!regimens!into!A+M2,!A+M3!and!A+M5!for!children!aged!2!months!to!5!years,!young!adults!aged!6!to!15!years!and!adults!aged!greater!than!15!years!respectively.!

For! severe!malaria,! intravenous! artesunate!was! introduced! as! the! firstTline! treatment.! If!intravenous! artesunate! is! not! available! then! intramuscular! artemether! is! recommended!followed!by!a!full!course!of!DHATPIP!+!PQ!once!the!patient!can!swallow.!

1.6.!Malaria!Control!Strategy

Evidence! of! the! development! of! artemisinin! drug! tolerance! began! appearing! along! the!ThaiTCambodian! border! in! the! midT2000s14T18.! Factors! believed! to! be! contributing! to!emerging! drug! resistance! in! Cambodia! include! the! unregulated! sale! of! artemisinin!monotherapies!for!over!40!years;!limited!access!to!ACTs;!coTblistered!ACTs!that!are!not!coTformulated! (facilitating! continued! use! of! artemisinin! monotherapy);! and! ubiquitous!counterfeit! and! substandard! drugs9.! Over! the! past! 10! years,! the! CNM! has! initiated!innovative!approaches!for!controlling!malaria!and!containing!artemisinin!resistance.!

In! 2009,! the!World! Health! Organisation! (WHO)! in! collaboration! with! the!MOHs! of! both!Cambodia!and!Thailand,!through!funding!from!the!Bill!&!Melinda!Gates!Foundation,!began!implementing! a! containment! program! targeting! the! development! of! artemisinin! drug!resistance! in! malaria! parasites! along! the! ThaiTCambodian! border.! The! containment!program! received! $22.5! million! in! 2008! for! initial! activities! over! two! years,! with!implementation!commencing!in!2009.!The!program!consisted!of!a!number!of!interventions!to! facilitate! the! early! diagnosis! and! appropriate! treatment! of! malaria! in! areas! where!artemisinin! tolerance!was! at! risk! of! developing! (CNM! zone! 2)! and! in! other! areas!where!tolerance!had!already!been!confirmed!(CNM!zone!1).!The!program!provided!services!to!13!provinces!and!approximately!4.3!million!people20.!

In! 2001,! the! CNM! introduced! the! Village! Malaria! Worker! (VMW)! program! in! order! to!improve! early! diagnosis! and! treatment! of! malaria,! particularly! in! remote! and! forested!areas.!This!project!was!initiated!in!a!remote!province!in!2001!and!gradually!expanded!until!2008,! identifying! malariaTprone! villages,! where! two! VMWs! were! selected! through!community!consensus!in!each!village.!Trained!VMWs!are!supposed!to!perform!RDTs!on!any!villager! suspected! of! having! malaria,! to! provide! antimalarials! for! testTpositive! cases!according!to!the!national!guidelines,!and!to!refer!severe!cases!to!hospitals.!They!are!also!encouraged! to! record! fever! cases! and! positive! RDT! results,! follow! up!with! patients,! and!provide! information! on!malaria! preventive! measures! to! their! villages.! Staff! of! the! CNM!assist!and!supervise!VMWs!by!checking!the!VMWs'!records,!resupplying!RDT!test!kits!and!

Page 12: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 8!

medications!and!by!visiting!the!VMWs!twice!yearly!to!monitor!their!activities!and!observe!their!relationships!and!communication!with!villagers.!

Since!2009,!the!program!has!been!scaled!up!as!part!of!the!containment!resistance!efforts;!2,000! new! VMWs! received! training;! the! number! of! villages! participating! in! the! program!increased! from! 315! in! seven! provinces! to! 1,394! in! 17! provinces;! and! the! range! of! the!project's!health!services!was!expanded.!Services!provided!by!VMWs!have!been!integrated!into! Cambodia's! Integrated! Management! of! Childhood! Illnesses! (IMCI)! protocol! and! a!number! of! VMWs! have! been! trained! to! provide! diagnostic! services! and! treatment! for!pneumonia!and!diarrhea.20!

Other!national!malaria!control!efforts! include!the!provision!of!highly!subsidized!RDTs!and!ACT! treatment! in! the! private! sector.! PSI! has! managed! a! nationwide! subsidized! private!sector! malaria! treatment! program! in! Cambodia! since! 2003.! Private! sector! artesunate!mefloquine!(ASMQ)!is!sold!under!the!brand!name!Malarine.!RDTs!are!sold!under!the!brand!name!Malacheck,! which! initially! just! tested! for! Pf! infections.! In! 2010,! the! diagnostic! kit!changed! to! test! for! both!Pf! and!Pv! infections.!Malarine! and!Malacheck! are! sold! in! over!1,700! outlets,! including! private! hospitals,! clinics,! pharmacies,!mobile! providers! and! drug!stores.!These!products!are!sold!by!PSI!at!subsidized!prices!(US$0.42!for!one!pack/dose!of!Malarine!Adult! and!US$0.05! for! one!Malacheck!RDT!unit)! that! are!much! lower! than! the!recommended!selling!price!(US$0.61!for!one!pack/dose!of!Malarine!Adult!and!US$0.24!for!one!Malacheck!RDT!unit).!In!the!public!sector,!ASMQ!is!available!under!the!name!A+M!and!is!preTpackaged!with!ageTspecific!dosing!regiments!for!children!aged!2!months!to!5!years!(A+M2),!children!6!years!to!15!years!(A+M3),!and!adults!(A+M4).!Rapid!diagnostic!testing!and! antimalarial!medicines! (A+M! brands)! are! provided! free! of! charge! by! VMWs! and! by!health!providers!in!public!health!facilities.!

The!widespread! availability! of! counterfeit! and! subTstandard! quality! drugs,! as!well! as! the!availability!of!oral!artemisinin!monotherapy,!has!compromised!malaria!treatment!efforts!in!Cambodia9,21.! Both! counterfeit! artemisininTbased! drugs21! and! oral! artemisinin!monotherapies! have! historically! been! cheaper! than! ACTs22! in! Cambodia,! fuelling! their!consumption.! The! Cambodian! government! has! taken! significant! steps! to! regulate! the!pharmaceutical! industry.!Oral!artemisinin!monotherapies!have!been!banned! in!Cambodia!since! 200823! and! market! authorization! for! all! oral! artemisinin! monotherapies! was!withdrawn! in! March! 200924.! The! Cambodian! MOH! has! also! targeted! unlicensed!pharmaceutical! outlets,! ordering! the! closure! of! all! unlicensed! pharmaceutical! outlets!resulting! in! an! observed! 65%! reduction! of! outlets! between! November! 2009! and!March!20109.!Efforts!are!also!being!made!to!detect!and!eliminate!poorTquality!medicines!through!surveillance!activities!in!17!provinces!and!to!raise!awareness!about!drug!quality!and!correct!treatment!procedures!among!drug!dispensers!and!the!public25.!Drug!inspectors,!under!the!title! of! “Justice! Police”,! are! enforcing! the! bans! through! outlet! inspections,! drug!confiscation,!fines,!and!prosecution22.!

Page 13: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 9!

1.7.!Malaria!Treatment!in!the!Public!and!Private!Sectors!

In!2011,!PSI!conducted!a!nationally!representative!household!survey!to!monitor!consumer!treatmentTseeking! behaviors! including! malaria! blood! diagnostic! testing,! choice! of!antimalarial,!and!price!paid!for!treatment26.!Data!was!also!collected!on!the!determinants!of!appropriate! treatment! seeking! behaviors! including! knowledge,! beliefs! and! attitudes! in!household!members!of!all!ages.

The!study! found! that!of! those!seeking!advice!or! treatment! for! fever,!76%!of!participants!accessed!private!sector!facilities!while!only!18.5%!did!so!in!the!public!sector.!These!results!highlight! the! important! role! that! the! private! sector! plays! in! fever! treatment! but! are! not!surprising! as! the! use! of! private! providers! is! generally! considered! to! be! widespread!throughout! the! country.! The! household! survey! also! revealed! that! 43.5%! of! respondents!with!malaria! fever!had!received!a!diagnostic! test!of!which!65.1%!of! tests!were!RDTs!and!27.0%!were!microscopy.!

In! Cambodia! it! is! extremely! common! for! individuals! with! malaria! to! be! provided! drug!cocktails26,27.! Drug! cocktails! include! a! wide! range! of! medicines,! with! or! without! an!antimalarial,! that! are! often! assembled! in! a! small! bag.! According! to! the! 2011! household!survey!61.3%!of!participants!reported!receiving!a!drug!cocktail!without!antimalarials!while!only!10.2%!received!antimalarial!medicines.!Although,!it!is!difficult!for!participants!to!truly!identify!whether!cocktails! include!an!antimalarial!or!not! (as! they!are!not!clearly! labeled),!other!research!assessing!malaria!medicine!supply!has!also!found!substantial!availability!of!cocktails!in!the!private!sector27.!

Of!participants!seeking!treatment!for!malaria,!27.5%!took!antimalarials.!The!percentage!of!participants!who! took!ACTs,! nonTartemisinin!monotherapy! and! artemisinin!monotherapy!was! 19.1%,! 7.8%! and! 0.9%! respectively.! Supply! side! studies! show! differing! patterns! of!antimalarial! volumes! within! the! public! and! private! sectors.! Volumes! of! artemisinin!combination!therapy!in!the!public!sector!is!relatively!higher!than!that!in!the!private!sector!while!the!reverse!is!true!for!nonTartemisinin!therapy26,27.!! !

Page 14: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 10!

2.!Methodology!for!Outlet!Surveys!

2.1.!General!Study!Design!

The! outlet! survey! study! design! employs! a! crossTsectional! stratified! oneTstage! cluster!design.!In!total,!98!communes!will!be!randomly!selected!across!three!domains!defined!by!levels!of!artemisinin!tolerance.!Data!collection!for!the!baseline!survey!will!take!place!during!September!and!the!first!two!weeks!of!October!2013,!coinciding!with!the!end!of!the!rainy!season.!A!full!schedule!of!study!events!for!the!2013!outlet!survey!can!be!found!in!Annex!2.!Factors! related! to! existing! research! plans! and! feasibility! of! data! collection! are! also!considered! when! planning! the! baseline! surveys.! The! second! phase! of! data! collection! is!planned!to!take!place!in!2015.!

2.1.1.!Sampling!Frame!and!Stratification!

The!last!population!census!was!conducted!in!2008!and!listed!communes!will!be!used!as!the!sampling!frame!for!the!2013!outlet!survey.!The!desired!cluster!size!for!the!outlet!survey!is!approximately! 10,000! to! 15,000! inhabitants,! which! corresponds! most! closely! to! a!commune! in! Cambodia! (Table! 1).! All! 1,207!malaria! endemic! communes!will! be! listed! as!potential!clusters.!Commune!populations!were!determined!by!the!Ministry!of!Planning! in!2010! and! will! be! used! in! the! sampling! frame.! The! most! recent! CNM! National! Zone!Designation!Database!will!be!used!to!classify!communes! into!three!domains!according!to!artemisinin!tolerance:!

1. Domain!1!=!Zone!1,!artemisinin!tolerance!confirmed!!2. Domain!2!=!Zone!2,!artemisinin!tolerance!suspected/buffer!area!!3. Domain!3!=!Zone!3,!artemisinin!tolerance!free;!and!areas!without!a!zone!designation!!

Any!communes!that!include!more!than!one!zone!will!be!allocated!to!the!most!appropriate!domain,!after!consulting!with!CNM!and!other!stakeholders.!

Table!1.! Level,!number!and!approximate!average!population!of!administrative!levels!in!

Cambodia!according!to!the!2008!Cambodia!Population!Census.!

Level! Number! ~!Average!Population!

Province! 24*! 560,000!

District!(Khan)! 159! 70,000!

Commune!(Sangkat)! 1,417! 8,000!

Village! 14,073! 900!! *!23!provinces!and!the!special!administrative!municipality,!Phnom!Penh.!

2.1.2.!Questionnaires!

Research!questions!will!be!addressed!through!two!primary!data!collection!activities,!each!with!its!own!data!collection!tool(s).!The!tools!will!be!piloted!before!the!studies!to!ensure!

Page 15: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 11!

questions! are! interpreted! correctly! by! the! respondents.! The! outlet! survey! tool! will! be!administered! in! 2013! and! again! in! 2015.! Key! Informant! Interviews! (KII)! will! also! be!performed! to! collect! data! complimentary! to! the!outlet! survey! findings.! These! interviews!will!be!conducted!in!2013!and!2015,!coinciding!with!the!outlet!surveys.!!

A!structured!questionnaire†!will!be!used!to!collect!data!on!outlet!characteristics,!provider!knowledge,! antimalarials! stocked,! RDTs! for! malaria! stocked! and! antimalarial! stock! outs.!Information!on! the! retail! price,!wholesale!price!and!volumes! sold/distributed! in! the!past!seven!days!will!be!collected!for!all!antimalarial!and!RDT!products.!RDTs!are!included!given!the!increased!importance!being!placed!on!confirmed!diagnosis!for!malaria,!and!the!need!to!interpret!ACT!volumes!in!the!light!of!RDT!use.!The!location!(geo!coordinates)!of!the!outlet!will! be! recorded!using!a!Global! Positioning! System! (GPS)!unit.! The!draft! questionnaire! is!appended!to!this!document!(Annex!3).!

The!outlet!survey!will!be!divided!into!two!main!parts.!In!the!first!part,!antimalarial!and!RDT!information!will!be!recorded!on!audit!sheets.!In!order!to!complete!this!section,!a!full!audit!of!the!antimalarials!and!RDTs! in!stock!on!the!day!of!the! interview!must!be!conducted.! In!the!second!part,!a!provider!module!will!collect!information!on!the!number!of!staff!present!in! the!outlet!or! facility,! their! level!of!education,!provider! knowledge,!perceptions!on! the!most! effective! treatment! and!other! characteristics! related! to! storage! and! registration! of!the!outlet.!The!most!senior!staff!member!available!in!the!outlet!or!facility!on!the!day!of!the!interview!will!complete!the!questionnaire.!

The! KIIs! follow! a! semiTstructured! interview! methodology.! Questions! in! the! KII! aim! to!capture!additional!detail!regarding!the!changes!in!malaria!markets!and!policies!influencing!the!market!dynamics!that!cannot!be!captured!through!the!outlet!survey.!Interview!topics!are!appended!to!this!document!(Annex!4).!

2.1.3.!Adaptation!of!Questionnaire!

The! questionnaire! was! first! developed! in! English.! PSI! Cambodia,! in! collaboration! with!ACTwatch,!made!minor!adaptations!to!the!coding!of!certain!questions!in!the!outlet!survey!questionnaire! to! cater! for! countryTspecific! categories! (e.g.! names! of! administrative!boundaries,! types! of! antimalarial! outlets,! titles! of! health! worker! cadres,! firstTline!antimalarial! treatment,! licenses! and! permits,! local! currency).! In! addition! PSI! Cambodia!gathered!as!wide!a!range!as!possible!of!antimalarials!currently!on!the!market! in!order!to!assess! the! feasibility! of! completing! the! antimalarial! audit!module,! and! to! use! in! training!and! in! developing! a! visual! aid! for! data! collectors.! PSI! Cambodia! will! be! responsible! for!translation!(and!blind!backTtranslation)!of!the!questionnaire!into!Khmer.!

! !

† This!questionnaire!is!adapted!from!the!ACTwatch!outlet!survey!questionnaire!ACTwatch!Outlet!Survey!(2011),!Round!2!Questionnaire.!Population!Services!International,!Department!of!Malaria!and!Child!Survival,!ACTwatch!Group.!

Page 16: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 12!

2.2.!Indicators!

The! following! indicators! will! be! measured! through! the! outlet! survey.! Results! will! be!presented!for!outlet!types!within!each!strata,!as!appropriate,!and!nationally.!!

Table!2.!Indicators:!Availability,!Price,!Volumes,!Knowledge!&!Provider!Perceptions.!ACTs!

are!categorized!as!either:!

1. WHO/UNICEF!approved!ACTs!(qualityEassured!ACTs!or!QAACTs)‡!

2. Nationally!registered!ACTs!3. NonEqualityEassured!ACTs.!

1.!Availability!!

i.! Proportion!of!outlets!that!had!antimalarials!in!stock!at!the!time!of!survey!visit.!ii.!! Proportion!of!outlets!that!had!nonTartemisinin!therapy!in!stock!at!the!time!of!survey!visit!

(among!outlets!with!antimalarials!in!stock).!iii.!!Proportion!of!outlets!that!had!artemisinin!monotherapy!in!stock!at!the!time!of!survey!visit!

(among!outlets!with!antimalarials!in!stock).!iv.!!Proportion!of!outlets!that!had!ACTs!in!stock!at!the!time!of!survey!visit!(among!outlets!with!

antimalarials!in!stock).!v.!! Proportion!of!outlets!reporting!no!disruption!in!stock!of!any!antimalarial!/!ACT!/!QAACT!in!

the!past!three!months.!vi.! Proportion!of!outlets!reporting!no!disruption!in!stock!of!any!antimalarial!/!ACT!/!QAACT!in!

the!past!two!weeks.!vii.!Proportion!of!outlets!that!have!either!RDTs!or!microscopic!blood!testing!facilities.!!

!

2.!Price!

i.!! Median!cost!of!a!full!adult!course!of!the!most!popular!nonTACT!antimalarial!(defined!as!the!antimalarial!with!the!largest!market!share!for!sales/distribution!in!the!past!7!days).!

ii.!! Median!cost!of!a!full!course!of!an!adult!treatment!of!ACT.!iii.!!Median!cost!to!patient!of!a!full!course!of!an!adult!treatment!of!ACT!relative!to!minimum!daily!

wage!of!a!government!unskilled!worker.!!iv.!Median!cost!to!patient!of!a!full!course!of!an!adult!treatment!of!ACT!relative!to!cost!of!the!

most!popular!full!course!adult!treatment!(nonTACT)!antimalarial.!vi.!!Median!cost!to!patient!of!a!full!course!of!an!adult!treatment!of!ACT!relative!to!international!

reference!prices.!!vii.!Percent!markup!between!the!median!retail!price!of!a!full!course!adult!treatment!of!ACT!and!

the!median!wholesale!purchase!price.!!

3.!Volumes!

i.! Total!volume!of!ACT!sold!or!distributed!in!the!last!week!as!a!proportion!of!the!total!volume!of!all!antimalarials!sold!or!distributed!in!the!last!week.!

ii.! Total!volume!of!nonTartemisinin!therapies!sold!or!distributed!in!the!last!week!as!a!proportion!of!the!total!volume!of!all!antimalarials!sold!or!distributed!in!the!last!week.!

iii.! Total!volume!of!artemisinin!monotherapies!sold!or!distributed!in!the!last!week!as!a!proportion!of!the!total!volume!of!all!antimalarials!sold!or!distributed!in!the!last!week.!

‡!A!list!of!all!QAACTs!according!to!the!Global!Fund!Quality!Assurance!Policy!is!provided!in!Annex!1.!!

Page 17: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 13!

!

4.!Knowledge!&!Provider!Perceptions!!

i.!! Proportion!of!providers!that!report!a!quality!assured!ACT!is!the!most!popular!antimalarial.!ii.! Proportion! of! providers! that! correctly! state! the! recommended! firstTline! treatment! for!

uncomplicated!malaria.!iii.! Proportion!of!providers!that!correctly!state!the!dosing!regimen!for!an!adult!of!the!firstTline!

treatment!ACT.!!

2.3.!Sampling!Outlets!

The!target!sampling!units!are!all!types!of!outlets!that!have!the!potential!to!sell!or!provide!antimalarials!or!diagnostic!tests!for!malaria!in!Cambodia.!The!outlets!are!classified!into!two!main!categories:!

Category! 1:! public! health! facilities! (referral! hospitals,! health! centres! or! subThealth!centres,!former!district!hospitals,!and!health!posts)!

Category! 2:! other! antimalarial! drug! sellers,! including,! village!malaria! workers,! private!notTforTprofit!health!facilities,!private!for!profit!health!facilities!(private!hospitals,!clinics,!poly! clinics,! depot! A! and! B,! and! cabinets),! pharmacies,! drug! stores,! general! retailers,!mobile!providers!and!diagnostic!labs.!

2.3.1.!Selection!Procedures!for!the!Communes!

The! sample! will! be! selected! using! a! stratified! cluster! design,! with! the! different! zones!constituting!the!three!strata.!A!probability!sample!of!21!locations!out!of!44!will!be!selected!from!domain!one,!22!out!of!242!from!domain!two!and!55!out!of!921!from!domain!three,!giving!a!total!of!98!communes.!Within!domain!three,!implicit!stratification!will!be!used!to!ensure!a!proportional!allocation!of!communes!from!zone!three!and!no!zone!areas.!A!list!of!selected!communes!can!be!found!in!Annex!5.!

In! each! selected! commune,! a! census! of! all! Category! 1! and! Category! 2! outlets! will! be!conducted.!All! outlets! that! stock! antimalarials! at! the! time!of! the! survey!or! in! the!past! 3!months,!or!who!stock!diagnostic!tests!for!malaria!on!the!day!of!the!survey,!will!be!eligible!for!interview.!

2.3.2.!Selection!Procedures!for!the!Booster!Sample!

The!sample!will!be!supplemented!by!a!booster!sample!of!Category!1!outlets!(public!health!facilities)! operating! in! the! district! of! the! sampled! commune.! Oversampling! will! ensure!adequate! representation! of! these! relatively! rare! but! important! outlets.! All! public! health!facilities! located! in! the! corresponding!district!of! the! sampled! commune!will! be! included.!Based!on!previous!ACTwatch! surveys,! village!malaria!workers!will! not!be! included! in! the!booster!sample!given!that! the!estimated!sample!size!of!village!malaria!workers! in! the!98!selected!communes!is!sufficient.!

Page 18: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 14!

2.3.3.!Identification!of!Outlets!

It!is!important!to!identify!all!outlets!in!the!selected!communes!that!are!currently!stocking!antimalarials! or! RDTs! or! report! having! stocked! them! in! the! past! three!months,! or! offer!diagnostic! tests! for!malaria.! It! is!well! known! that! in!addition! to!official!medicine!outlets,!such! as! health! facilities! and! licensed! pharmacies,! medicines! are! often! sold! through!"unofficial"! channels! (i.e.! outlets! that! are! not! officially! permitted! by! pharmaceutical!regulations!to!sell!medicines).!In!some!settings!these!unofficial!channels!are!an!important!source!of!medicines,! especially! in! geographically! isolated! areas! and! for! customers! in! the!poorest!groups.!Therefore,!it!is!very!important!to!include!these!outlet!types!in!the!survey!in!order!to!better!understand!their!stocking!and!pricing!practices.!

All! outlets! in! the! selected! subTcounties! that! could! potentially! stock! manufactured!medicines!or!diagnostics!will!therefore!be!considered!as!"eligible"!for!the!outlet!survey,!and!will! be! visited! by! the! survey! team! (though! only! those! answering! "yes"! to! one! of! the!screening!questions!on!antimalarial!or!RDT!stocking!described!in!the!questionnaire!will!be!invited!to!complete!the!full!questionnaire,!which!will!be!administered!immediately!where!possible).!

PSI!Cambodia!has!identified!outlet!types!to!include!in!the!survey!by:!• Reviewing!regulatory!documents!to!see!what!type!of!outlets!are! legally!permitted!to!

sell!antimalarials;!!• Reviewing! existing! household! and! outlet! studies! on! medicine! availability! and!

treatment!seeking!behavior!in!Cambodia;!• Considering!which!outlet!types!are!sellers!of!other!"fast!moving!consumer!goods"!and!

may!therefore!stock!medicines!(e.g.!grocery!stores,!snack!bars,!market!stalls,!etc.)!!• Discussing!where!antimalarials!can!be! found!with!communityTlevel!key! informants! in!

rural!and!urban!areas!during!preTtesting;!• Identifying! categories! of! outlets! that! never! sell! drugs! and! are! therefore! not! eligible!

(e.g.!butcher!shops!and!hardware!stores).!!

Based! on! these! investigations,! PSI! Cambodia! has! created! the! following! classification! of!outlet!types,!which!may!stock!manufactured!medicines!or!provide!diagnostic!services.!!

1.! Referral!Hospital!2.! Health!Center!3.! Former!District!Hospital!4.! Health!Post!5.! Village!&!Mobile!Malaria!Workers!6.! NGO/Mission!FaithTbased!Hospital!7.! NGO/Mission!FaithTbased!Clinic!8.! Private!Hospital!9.! Private!Clinic/Poly!Clinic!10.! Clinical!Pharmacy/Pharmacy!

11.! Depot!A!Pharmacy!12.! Depot!B!Pharmacy!13.! Cabinet!14.! Drug!Store!15.! Grocery!Store!16.! Village!Shop!17.! Mobil!Provider!(only!mobile)!18.! Fixed!Clinic!(base!+!mobile)!19.! Diagnostic!Lab!

Page 19: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 15!

A!full!description!of!all!outlet!types!is!provided!in!Annex!6!

If! an! additional! outlet! category! is! found! to! be! stocking!medicines! during! fieldwork,!that! category! will! be! included! in! the! outlet! survey.! The! field! supervisor! should!immediately!inform!the!PSI!Cambodia!team!who!can!alert!other!field!teams!to!include!this!outlet!category!in!the!questionnaire.!

Particular!challenges!arise!in!the!identification!of!"itinerant"!or!travelling!sales!people!stocking!drugs.!Lessons!can!be!learnt!from!PSI’s!experience!with!the!ACTwatch!project!in!Nigeria!where!itinerant!sellers!were!identified!most!readily!in!the!evenings!at!travel!centers,!or!at!market!places.!If!a!particular!itinerant!seller!is!identified!more!than!once!within!the!same!commune,!only!one!questionnaire!should!be!completed.!However,!if!the!same!individual!happened!to!be! identified! in!another!commune!(e.g.!on!another!day),!then!a!second!questionnaire!would!be!completed!for!this!seller,!representing!the!"snapshot"!of!drug!availability!during!the!course!of!the!survey.!

Note! that! there! is! an! important! role! for! supervisors! and! field! coordinators! in! the!process!of! identifying!all!eligible!outlets! in!a!commune,!as! interviewers!will!not!have!an!incentive!to!search!exhaustively,!since!this!leads!to!more!work!for!them.!

Records!will!be!kept!of!closed!outlets.! If!outlets!are!not!permanently!"closed!down"!interviewers!will!try!to!make!a!minimum!of!two!callTbacks!to!these!outlets.!!!

2.4.!Sample!Size!

This!survey!will!primarily!measure!differences! in! indicators!over!time!within!the!public!and!private! sectors!within!each!domain.!Given! the!planned! sample! size! it!will! also!be!possible!to!measure!a)!differences!over!time!for!a!given!domain!(among!all!outlets),!and!b)!differences!between!domains!at!a!given!point!in!time!(among!all!outlets).!Given!the!sample!sizes!achieved!it!may!additionally!be!possible!for!secondary!comparisons!to!be!made!at!the!outletTtype!level,!either!over!time!or!across!domains.!!

The!sample!size!calculations!are!maximized!based!on!the!ability!to!detect!at!least!a!20!percentage!point! change! (increase)! in! the! indicator,! the!proportion!of!private! sector!outlets! that! have!ACT! in! stock!among!all! private! sector! outlets!with!antimalarials! in!stock!at!the!time!of!the!survey.!

The!required!sample!size!is!calculated!in!3!steps:!

1. Determining!the!required!number!of!outlets!with!antimalarials!in!stock!on!the!day!of!the!survey.!

2. Determining!the!number!of!outlets!that!must!be!enumerated!to!arrive!at!this!number!of!antimalarialTselling!outlets!(the!gross!sample!size).!

3. Determining! the! number! of! clusters! that! must! be! visited! to! arrive! at! this!number!of!outlets!(the!operational!sample!size).!

Page 20: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 16!

2.4.1!Required!Number!of!Outlets!

The! sample! size! required! to! detect! a! change! over! time! in! private! sector! outlets!between!survey!rounds!is!given!by:!

!

!

where:!n!=!desired!sample!size!P1! =! the! hypothesized! value! of! the! indicator! at! time! 1! (the! proportion! of! outlets!with!ACTs! in!stock!among!all!outlets!with!antimalarials! in!stock!on!the!day!of! the!survey)!P2!=!the!expected!value!of!the!indicator!at!time!2!(a!20!percentage!point!difference!will!be!desired;!a!20%!point!change!is!the!minimum!change!felt!necessary!to!justify!the!importance!in!public!health!policy!terms)!P!=!(P1+P2)/2!Zα!=!the!standard!normal!deviate!value!for!an!α!type!I!error!(oneTsided)!Z1Tβ!=!the!standard!normal!deviate!value!for!a!c!type!II!error!deff§!=!the!design!effect!in!case!of!multiTstage!cluster!sample!design!

The! required! size! for! the! 2013! survey! has! been! calculated! based! on! the! following!estimated!values!of!P1!taken!from!the!2011!ACTwatch!survey,!and!a!deff!value!of!3:!

!

!!!!

!

In!addition,!the!following!values!for!key!parameters!were!used:!Zα/2!=!1.64,!corresponding!to!an!α!(type!I)!error!of!5%!with!a!oneTsided!test!Z1Tβ!=!0.84,!corresponding!to!a!test!power!of!80%!(or!a!type!II!error!of!20%)!

The! required! sample! sizes,! calculated! by!maximizing! the! above! formula! in! order! to!produce!the!most!conservative!estimates,!are!186!outlets!in!domain!1,!204!outlets!in!domain!2,!and!226!outlets!in!domain!3.!

These! figures! are! the! denominator! for! the!ACT! availability! indicator:! the! number! of!private! sector! outlets! that! have! any! kind! of! antimalarial! in! stock! on! the! day! of! the!survey.!

§ The!deff!figures!are!estimated!across!a!range!of!availability!indicators!from!the!2011!data.

! !!!!!!!!!!Domain!1! !!!!!!!!!!!Domain!2! !!!!!!!!!!!Domain!3!! !!!!!!!!!!Zone!1! !!!!!!!!!!!Zone!2! !!!!!!!!!!!Zone!3!

!!!!!!!!!!!No!Zone!P1! 0.61! !!!!!0.56! !!!!!0.45!deff! 3! !!!!!3! !!!!!3!

n = deff Zα 2P(1− P) + Z1−β P1(1− P1)+ P2 (1− P2 )⎡⎣ ⎤⎦2

(P2 − P1)2

Page 21: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 17!

2.4.2.!Required!Number!of!Outlets!to!be!Enumerated!

The!estimated!gross!sample!size!T!the!number!of!outlets!enumerated!T!needed!for!the!ACT! availability! indicator! is! determined! for! each! domain! separately,! using! the!following!formula:!

!!

where:!N! =! the! desired! sample! size! of! all! private! sector! outlets! for!monitoring! the! ACT!availability!indicator!n!=!the!number!of!private!sector!outlets!with!antimalarial!stocks!at!the!time!of!the!survey!Pam!=!the!proportion!of!private!sector!outlets!having!any!antimalarial!in!stock!at!the!time!of!the!survey!among!all!outlets!enumerated!

The!table!below!presents!the!estimates!for!Pam!from!the!2011!results!and!the!required!gross!sample!sizes!calculated!using!the!above!formula.!!

! !!!!!!!!!!!!Domain!1! !!!!!!!!!!!!!Domain!2! !!!!!!!!!!Domain!3!!

!!!!!!!!!!!!Zone!1! !!!!!!!!!!!!!Zone!2!!!!!!!!!!!Zone!3!and!!!!!!!!!!...TTTTTNo!Zone!

n! !!!!!186! !!!!!204! !!!!!226!Pam! !!!!!0.07! !!!!!0.05! !!!!!0.03!N! !!!!!2,548! !!!!!4,000! !!!!!8,072!

!Thus!a!total!of!2,548!outlets!in!domain!1,!4,000!outlets!in!domain!2!and!8,072!outlets!in!domain!3!must!be!interviewed!in!order!to!detect!a!20!percentage!point!change!in!ACT!availability!in!private!sector!outlets!between!2011!and!2013.!

2.4.3!Required!Number!of!Clusters!!

To!convert!the!gross!sample!size!into!the!required!numbers!of!clusters,!we!apply!the!estimated! average! number! of! private! sector! outlets! screened! per! cluster! for! each!domain.!The!number!of!outlets!needed!to!reach!the!required!gross!sample!size!may!be! different! for! the! three! domains! depending! on! the! average! number! of! outlets!screened!per!cluster.!We!used!the!average!number!of!screened!outlets,!and!not!the!number! of! enumerated! outlets,! to! implicitly! account! for! incomplete! interviews! and!refusals.!

The!2011!ACTwatch!survey!results!show!that!there!are!on!average!121,!186!and!149!private! sector!outlets! screened!per! cluster! in!domains!1,! 2! and!3! respectively.!After!applying! these! estimates,! the! minimum! number! of! clusters! required! to! reach! the!desired!number!of!outlets!in!each!domain!is!21!clusters!for!domain!1,!22!clusters!for!domain!2!and!55!clusters!for!domain!3.!

! !

amPnN /=

Page 22: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 18!

2.4.4.!Predicted!Number!of!Outlets!and!ACTs!

The! number! of! outlet! types! and! ACTs! audited! are! predicted! in! Table! 3! using! 2011!outlet!survey!data!of!the!number!of!outlets!per!cluster!in!domains!1,!2!and!3.!

Table!3.!Predicted!number!of!outlet!types!to!visit!and!ACTs!to!audit!by!domain.!

! !!!!!!!Domain!1! !!!!!!!Domain!2! !!!!!!!Domain!3! !! !!!!!!!Zone!1! !!!!!!!Zone!2! !!!!!!!Zone!3!

!!!!!!!No!Zone! Total!

Clusters!selected! 21! 22! 55! 98!

Predicted!number!of:! ! ! ! !

Public!health!facilities! !!!!!!!!!!!!21!! 54! 356! 431!Village!malaria!workers! 157! 72! 11! 240!Total!Public! 178! 126! 367! 671!

!Pharmacies/clinics! 54! 101! 191! 346!Drug!shops! 68! 76! 89! 232!Mobile!providers! 62! 171! 350! 583!SubEtotal!private!!

184! 347! 630! 1,161!

Groceries!/!village!shops! 2,365! 3,740! 7,560! 13,665!Total!Private! 2,549! 4,087! 8,189! 14,825!

Predicted!number!of!ACTs!audited!in:!

! ! ! !

Public!health!facilities! 27! 130! 608! 765!Village!malaria!workers! 146! 120! 47! 312!Total!Public! 174! 250! 655! 1,077!

!Pharmacies/clinics! 17! 47! 56! 120!Drug!shops! 10! 19! 11! 40!Mobile!providers! 12! 46! 45! 103!Groceries!/!village!shops! 14! 14! 4! 33!Total!Private! 53! 126! 117! 296%! !

Page 23: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 19!

2.5.!Sampling!Procedures!

Within!each!of!the!selected!communes,!interviewers!will!visit!all!outlets!that!have!the!potential!to!stock!any!type!of!antimalarial!medicines!or!provide!malaria!diagnostics.!A!number!of!methods!will!be!employed!before!and!during!data!collection!to!ensure!that!all!outlets!that!have!the!potential!to!sell!or!provide!antimalarial!medicines!or!malaria!diagnostics!are!visited.!

1.! Once!in!the!field,! interviewers!will!approach!the!district!head!for!permission!to!audit! providers.! For! the! census,! the! interviewer! will! contact! the! relevant!authority! in!the!area!to! inquire!about!places!that!typically!or!even!occasionally!stock!antimalarials!or!RDTs.!

2.!!Interviewers!will!obtain!a!list!of!all!public!health!facilities!in!the!selected!districts!from!the!national!or!lowerTlevel!health!departments.!A!booster!sample!of!public!health!facilities!will!be!obtained!up!to!the!district!level.!

3.! Supervisors!will! identify! a! number! of! potential! key! informants!who! can! guide!them! to! the! outlets! that! potentially! sell! drugs! T! this! would! include! health!officials,! but! should! go! beyond! this! group! to! other! local! government! officials,!and!traditional!authorities!at!the!local!level!and!other!well!informed!community!members.!Through!discussion!with!these!key!informants,!data!collectors!should!obtain!a!full!list!of!potential!medicine!outlets!in!their!area,!and!work!with!them!to!draw!up!a!rough!sketch!map!of!their!locations.!!

4.! Once!an!outlet!has!been!audited!and!the!provider!interviewed,!interviewers!will!ask!the!outlet!owners!or!assistants!about!any!other!outlets!in!the!area!that!may!typically!or!occasionally!stock!antimalarials!or!RDTs.!

For!outlets!where!antimalarial!medicines!or!RDTs!are!sold,!the!field!workers!will!give!information!on!the!study!and!ask!to!interview!the!main!provider!or!pharmacist,!given!this!person!is!most!likely!to!be!able!to!provide!reliable!information!related!to!volumes!and! stock! outs.! If! there! are!multiple! providers! working! in! a! single! outlet,! the!main!provider!will! be! asked! to! complete! the! interview.! If! he/she! is! unavailable,! the! next!most!senior!provider!will!be!invited!for!interview.!Prior!to!administering!the!drug!audit!module,!the!provider!will!be!asked!to!give!verbal!consent!using!the!informed!consent!procedures!described! in!Annex!7.!Once! consent!has!been!given,! full! details!on!each!available! antimalarial! medicine! and! RDT! will! be! gathered! using! the! drug! and! RDT!modules.! In!case!an!outlet! is! closed!or! the!provider! is! too!busy,! the! interviewer!will!arrange!to!come!back!at!another!time.!Records!will!be!kept!of!refusal!rates!as!well!as!outlets!that!were!closed!at!the!time!of!the!survey.!

In! public! hospitals,! appointments! will! be! made! with! medical! superintendents! and!upperTlevel! management! to! determine! the! best! methods! and! time! to! conduct! the!survey.! Key! persons! to! contact! for! interviews! will! be! established! during! these!appointments.!CallTbacks!will!be!made!on!appointment!with!the!provider.!A!maximum!

Page 24: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 20!

of! two! callTbacks! will! be! made! at! a! given! outlet! (i.e.! three! visits! in! total).! Field!interviewers!will!be!encouraged!to!make!appointments!on!the!same!day!as!the!initial!visit!and!at!a!time!convenient!for!the!provider!in!order!to!reduce!the!time!required!to!complete!interviews.!

Monitoring!sheets!will!be!checked!against! lists!of!all! selected!public!health! facilities.!Additional! lists!for!the!booster!sample!will!be!verified!using!the!original! list!of!public!health!facilities.!For!other!outlet!types,!a!complete!census!will!be!completed!by!field!workers! under! the! supervision! of! team! leaders,! the! research! agency! and! the! PSI!Cambodia!research!team.!Local!area!leaders!will!provide!additional!information!about!the!location!and!distribution!of!the!different!outlets.!!

Before! data! collection,! initial! lists! of! all! registered! public! health! facilities! in! the!selected!communes!and!corresponding!districts! from!the!MOH!will!be!obtained.!Key!informants! living! or! working! in! the! commune! will! also! be! interviewed! to! identify!outlets! or! outlet! listings.! After! interviews! are! completed,! interviewers! will! ask!providers!to!identify!nearby!outlets.!

All!outlets!will!be!mapped!using!a!GPS!unit.!A!longitudinal!and!latitudinal!reading!will!be!taken!for!each!outlet!and!recorded.!Records!of!these!outlets!and!their!location!will!be! kept! to! build! a! sampling! frame.! Once! interviewers! find! an! outlet,! six! screening!questions!will!be!asked!to!ascertain! if! the!outlet!should!be!audited!and!the!provider!interviewed.!The!screening!questions!are:!

1. Do!you!have!any!medicines!in!stock!today?!2. Are!there!any!medicines!that!are!out!of!stock!today,!but!that!you!stocked!in!the!

past!3!months?!3. Do!you!have!any!antimalarial!medicines!in!stock!today?!4. Are! there!any!antimalarial!medicines! that!are!out!of! stock! today,!but! that!you!

stocked!in!the!past!three!months?!5. Are!you!offering!any!diagnostic!services!or!selling!any!diagnostic!tests!here!today?!6. Are!any!of!these!services!or!tests!for!suspected!malaria?!

Data!collection!will!take!place!during!peak!working!hours.! In!towns!and!urban!areas,!health!facilities!and!private!businesses!usually!remain!open!all!day.!However,!in!rural!areas,!outlets!typically!open!in!the!afternoon!and!don't!close!until!late!in!the!evening.!Data!collection!will!be!planned!to!accommodate!for!these!fluctuations!in!time.!

Paper! questionnaires! will! be! used! for! data! collection.! The! questionnaire! has! been!checked! and! tested! for! clarity,! sequence! of! questions! and! skip! patterns.! Other!documents! such! as! antimalarial! lists! and! the! Interviewer’s! Field! Manual! will! be!provided!as!reference!documents.!

Page 25: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 21!

3.!Research!Team!

Data!will!be!collected!by!a!team!of!field!workers!hired!by!PSI!Cambodia.!There!will!be!approximately! six! data! collection! teams! each! with! five! research! assistants! (field!workers),! one! quality! controller,! and! one! supervisor.! The! number! of! research!assistants!per! team!will!depend!on!the!size!and!scope!of!work!to!be!completed!(i.e.!urban!areas!with!many!outlets!will!be!surveyed!by!larger!data!collection!teams).!!Each!team!will!be! led!by!a! supervisor,!who!will!be! selected!on! the!basis!of!previous!data!collection!experience,!demonstrated!excellence!during!the!outlet!survey!training,!and!proven!leadership!skills.!Supervisors!will!also!be!capable!of!administering!the!survey.!Quality!controllers!will!be!responsible!for!monitoring!completed!surveys!for!errors!and!for!ensuring!a!full!census!of!all!outlets!with!the!potential!to!sell!antimalarials!or!RDTs!is!conducted.!!

4.!Quality!Control!Measures!

Quality!control!of!data!collection!and!management!will!be!provided!at!two!levels:!

1.!PSI!Cambodia!will!undertake!internal!quality!control.!This!will!include:!!

• Appropriate!and!rigorous!selection!and!training!of!fieldworkers.!• Following! the! procedures! set! out! by! the! ACTwatch! central! team! in! the!

supporting!documents!which!include!questionnaire!adaptation!and!translation!standard! operating! procedures,! training! materials,! field! manuals,! data!collection! monitoring! forms,! data! entry! instructions! and! data! cleaning! and!analysis!guidelines.!!

• Daily! supervision! of! data! collection,! including! accompanied! interviews,!checking! completed! questionnaires,! and! ensuring! that! all! potentially! eligible!outlets!are!visited.!

• Spot! checks! of! a! random! sample! of! 5%! of! outlets! censused! which! met! the!screening!criteria!and!5%!that!did!not.!For!those!meeting!the!screening!criteria,!this! does! not! need! to! entail! a! full! repeat! of! the! questionnaire,! but! rather! a!quality! control! visit! to! assess! if! the! interview! was! completed,! if! a! few! key!questions! were! answered! appropriately,! and! if! roughly! the! right! number! of!antimalarial!and!RDT!products!were!recorded!(it!is!not!possible!to!assess!if!the!right!number!of!products!were!recorded!as!stocks!may!have!changed!between!the!interview!and!the!spot!check).!For!those!not!meeting!the!screening!criteria,!the! spot! check! should! verify! that! the! screening! criteria! were! completed!correctly.! This! is! to! ensure! that! interviewers! don’t! report! “No”! to! these!questions!just!to!skip!the!outlet!and!reduce!their!workload.!

2.!The!ACTwatch!Central!team!will!undertake!external!quality!control.!This!will!include:!

• Provision!of!detailed!supporting!documents!for!each!element!of!data!collection!and!management.!!

Page 26: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 22!

• Checking!adherence!to!study!procedures!through!written!reports!from!Country!Project!Coordinators!and!field!supervisors,!including!completion!of!checklists.!

• Visits!to!study!countries!to!assess!adherence!to!study!procedures.!• Provision! of! standardized! field! manuals! and! detailed! training! materials!

including!detailed!power!point!presentations,!and!activities.!!• Provision!of!forms!to!be!used!during!data!collection!for!tracking!the!number!of!

completed!questionnaire,!documenting!problems!encountered!in!the!field,!and!questionnaires!to!be!used!during!spot!checks.!

• Provision! of! a! detailed! analysis! plan! to! ensure! correct! and! standardized!calculation!of!indicators!across!countries.!

5.!Training!

All!fieldworkers!will!undergo!training!prior!to!the!outlet!survey,!using!the!standardised!training!materials,!which!PSI!Cambodia!will!adapt!to!the!national!setting.!Fieldworkers!will!be!trained!for!a!total!of!7!days.!This!will!include!6!days!in!the!classroom,!and!1!day!in!the!field,!when!the!teams!will!practice!the!full!survey!methodology!in!one!commune!not! included! in!the!sample.!Training!will!educate!fieldworkers!on!the!purpose!of!the!study,! the! importance! of! consent,! how! to! administer! both! the! consent! forms! and!questionnaires!and!the!proper!use!of!the!GPS!units.!A!key!element!of!the!training!will!focus! on! identification! of! antimalarial!medicines,! including! the! differences! between!ACTs!and!nonTACTs,! trade!names!and!generics,!packaged!and! loose! tablets,! and! the!various! formulations.! Supervisors,! quality! controllers! and! fieldwork! coordinators!will!receive! an! additional! 1.5! days! training! to! learn! procedures! for! field! supervision! and!quality!control.!Training!will!be!repeated!prior!to!the!2015!outlet!survey.!!!

6.!Data!Management!!

Data!entry!will!occur!by!a!data!collection!agency!in!Cambodia.!Data!will!be!manually!entered!into!a!Microsoft!Access!database,!using!a!doubleTentry!process.!The!research!agency!will!check!for!coding!and!filter!errors,!incorrect!nonTresponses,!outlying!values!and! any! other! irregularities.! Data! entry! personnel!will! also! be! provided!with! a! data!entry!guide,!to!reduce!the!potential!for!errors.!!From!the!Access!database,!data!will!be!exported! to! Stata! which! will! be! used! for! the! analysis.! The! attribute! data! for! each!outlet! –! each! equaling! one! record! in! the! table! –!will! be! fully! labeled! along!with! its!value!codes.!!

A!trained!local!ACTwatch!staff!member!will!be!responsible!for!data!importing!and!for!initial!data!cleaning!and!validation.!!

7.!Analysis!Plan!

The! ACTwatch! central! team!will! perform! data! cleaning! and! analysis! recording! their!work!using!do!and!log!files!according!to!a!detailed!analysis!plan.!This!plan!will!contain!

Page 27: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 23!

instructions! for! data! cleaning,! data! weighting! and! the! calculation! of! key! indicators,!and! will! also! include! a! set! of! blank! tables! (known! as! a! tabulation! plan! or! dummy!tables).!

The! indicators! in! section! 2.2!will! be! calculated! as! specified! in! the! indicator! table! in!section!2.2,!and!will!also!be!presented!by!rural/urban!status!and!outlet!type.!All!core!indicators,!with!the!exception!of!indicator!1.6,!are!derived!from!the!drug!audit!module!and!screening!questions.!Additional!analysis!will!examine!possible!covariates!that!can!predict! differences! in! availability,! affordability,! and!market! share! of! qualityTassured!ACTs,! such!as!outlet!characteristics,!provider!knowledge,! registration!status,!and!the!availability!of!microscopic!testing!and!RDTs.!

8.!Ethical!Issues!

Data! will! be! collected! by! using! the! outlet! survey! questionnaire,! by! reviewing! key!NMCP,!MOH!and!other!malaria!related!documents,!and!by!conducting!KIIs.!Any!data!collected!during!this!study!will!be!used!for!the!aforementioned!research!objectives.!!

Confidentiality:! Results! will! not! be! linked! to! individual! providers,! outlets,! or! key!informants.!Every!effort!will!be!made!to!protect!the!confidentiality!and!the!identity!of!participants.! The! importance! of! confidentiality! and! the! protection! of! the! identity! of!outlets!will!be!emphasized!during!the!training!of!data!collection!staff.!!!

Individual!consent:!For!the!outlet!survey!and!KIIs,!consent!will!be!obtained!from!the!respondents.!Information!sheets!and!consent!forms!will!be!translated!into!Malagasy.!A! copy! of! the! information! sheet! will! be! left! for! the! interviewees.! The! information!sheet!will! include! an! introduction,! the! purpose! of! the! study,! how! questions!will! be!administered,!the!risks!and!benefits!to!those!who!participate!and!a!statement!that!the!data!collected!will!be!confidential!and!that!participation! is!voluntary.!Verbal!consent!will! be! obtained! and! witnessed! by! a! field! worker! prior! to! the! survey.! Verbal! as!opposed!to!written!consent!will!be!obtained!as!providers!in!many!drug!outlets!tend!to!be!cautious!of!inspectors!and!suspicious!of!having!to!sign!documents!that!may!be!used!to! identify! them! or! their! outlet/facility.! Information! sheets! and! consent! forms! are!included!in!Annex!7!for!the!outlet!survey!and!Annex!8!for!the!KIIs.!Care!will!be!taken!when! presenting! the! findings! from! KIIs! to! protect! the! identify! of! respondents! in!situations!where! there!are! small!numbers!of! interviewees! in!each!category!by!using!general!terms!to!describe! interviewees!such!as!"national! level!stakeholders!reported!that....".!

Participants!will!be!able!to!drop!out!at!anytime!during!the!survey!and!do!not!have!to!respond! to! questions! they! do! not! wish! to.! Reasons! for! not! participating! or! not!answering!questions!will!be!obtained.!!

Ethical!approval!will!be!obtained!from!Cambodia’s!National!Ethics!Committee!for!Health!Research.!

Page 28: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 24!

9.!Communication!and!Dissemination!

PSI!Cambodia!will! contact! key! stakeholders! to! inform! them!about! the!details!of! the!survey!prior! to! the! start!of!data! collection.! This!will! also!provide! the! study! team!an!opportunity!to!receive!comments!related!to!the!study!design.!!

ACTwatch!central!and!PSI!Cambodia!will!produce!a!survey!report,! following!a! report!structure! produced! by! the! ACTwatch! team.! The! report! will! outline! data! collection!procedures,!analysis!methods,!and!findings!on!key!indicators.!The!survey!report!will!be!submitted!to!the!MOH!for!review,!and!copied!to!donors.!Reports!will!be!reviewed!and!approved! by! the! ACTwatch! team! prior! to! dissemination! to! key! national! level!stakeholders.

Page 29: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 25!

Annex%1.% List%of%Artemisinin0based%Combination%Therapy%products%classified%according%to%the%Global%Fund%Quality%Assurance%Policy%(version%65,%March%1st%2013)%

International%Non0proprietary%name% Strength/%Dose% Dosage%

form% Supplier/Manufacturer% Global%Fund%QA%Standard%

WHO%Prequalification/SRA% Manufacturing%site% Country% Material% Pack%

Artemether!+!Lumefantrine!(FDC)! 20!mg!+!120!mg! Tablet! Novartis!Pharma! AAB! Yes! Beijing;!Suffern! China!USA! Blister! 6,!12,!18,!24!

Artemether!+!Lumefantrine!(FDC)! 20!mg!+!120!mg! Tablet! Ajanta!Pharma! A! Yes! Paithan,!Aurangabad! India!

PVC/PVdC/Alu!blister!

2*8,!3*8,!6*30,!12*30,!18*30,!24*30!

Artemether!+!Lumefantrine!(FDC)! 20!mg!+!120!mg! Tablet! Cipla!Ltd.! A! Yes!

Patalganga;!Goa!Kurkumbh!Indore;!Quality!Chemical!Industries!Ltd,!Kampala,!

India!Uganda!

PVCAPCTFEE/Alu!Blister!AluAAlu!Blister!

6,!12,!18,!24!6,!12,!18,!24!

Artemether!+!Lumefantrine!(FDC)! 20!mg!+!120!mg! Tablet! IPCA!Laboratories!Ltd! A! Yes! Dadra!and!Nagar!Haveli,! India!

Alu/PVC/PVDC!Blister! 6,!12,!18,!24!

Artemether!+!Lumefantrine!(FDC)! 20!mg!+!120!mg!

Dispersible!tablets! Novartis!Pharma! A! Yes! Novartis!Pharmaceuticals,!Suffern! USA!

PVC/Alu!blister!or!PVC/PCTFE/Alu!blister!

6*30;!12*30;!18*30!

Artemether!+!Lumefantrine!(FDC)! 20!mg!+!120!mg! Dispersibl

e!tablets! Ajanta!Pharma! A! Yes! Paithan,!Aurangabad,!Maharashtra! India! PVC/PVdC/Alu!blister! 6,!12!

Artesunate!+!Amodiaquine!(CoA!Blistered)! 50!mg!+!150!mg! Tablet! Guilin!Pharmaceutical!Co.!

Ltd! A! Yes! Guilin,!Guangxi,! China! PVC/ALU!blisters;! 3x(4+4),!3+3,!6+6,!12+12!

Artesunate!+!Amodiaquine!(CoA!Blistred)!

50!mg!+!153!mg!(200mg!as!Hydroclorine)!

Tablet! Cipla!Ltd.! A! Yes! Goa;!Patalanga! India!PVC/PVDC/Alu!blister!

3+3,!6+6,!12+12!

Artesunate!+!Amodiaquine!(CoA!Blistered)!

50!mg!+!153!mg!(200mg!as!Hydroclorine)!

Tablet! IPCA!Laboratories!Ltd! A! Yes! Dadra!and!Nagar!Haveli,! India!PVdC/PVC/Alu!blister!

12+12,!6+6,!3+3!

Artesunate!+!Amodiaquine!(CoA!Blistered)! 50!mg!+!153!mg! Tablet! Strides!Arcolab!Limited! A! Yes! Bangalore! India!

PVdC/PVC/Alu!blister!

10x(12+12),!10x(!6+6),!10x(3+3)!

Amodiaquine+Artesunate!(FDC)! 67.5!mg!+!25!mg! Tablet! Sanofi!Aventis! A! Yes! Maphar!Lab,Casablanca! Morocco! Al/Alu!Blister! 3*1,!3*25!

Amodiaquin(as!Hydrochloride)+Artesunate!(FDC)!

67.5!mg!+!25!mg! Tablet! IPCA!Laboratories!Ltd! A! Yes! Dadra!and!Nagar!Haveli,! India! Al/Alu!Blister! 10x1x3;!25x3!

Amodiaquin(as!Hydrochloride)+Artesunate!(FDC)!

67.5!mg!+!25!mg! Tablet!Guilin!Pharmaceutical!Co.!Ltd! A! Yes! Guilin,!Guangxi,!China! China!

Alu/PA/Alu/PVC!blister! 3!

Amodiaquine+Artesunate!(FDC)! 135!mg!+!50!mg! Tablet! Sanofi!Aventis! A! Yes! Maphar!Lab,Casablanca! Morocco! Al/Alu!Blister! 3*1,!3*25!

Page 30: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 26!

International%Non0proprietary%name% Strength/%Dose% Dosage%

form% Supplier/Manufacturer% Global%Fund%QA%Standard%

WHO%Prequalification/SRA% Manufacturing%site% Country% Material% Pack%

Amodiaquin(as!Hydrochloride)+Artesunate!(FDC)!

135!mg!+!50!mg! Tablet! IPCA!Laboratories!Ltd! A! Yes! Dadra!and!Nagar!Haveli,! India! Al/Alu!Blister! 10x1x3;!25x3!

Amodiaquin(as!Hydrochloride)+Artesunate!(FDC)!

135!mg!+!50!mg! Tablet!Guilin!Pharmaceutical!Co.!Ltd! A! Yes! Guilin,!Guangxi,!China! China!

Alu/PA/Alu/PVC!blister! 3!

Amodiaquine+Artesunate!(FDC)! 270!mg!+100!mg! Tablet! Sanofi!Aventis! A! Yes!

Maphar!Lab,Casablanca,!Morocco;!Rottendorf!Pharma,!Ennigerloh,!Germany;!Batch!released!by:!I41SanofiA!Aventis!Maroc,!Casablanca,!Morocco!

Morocco!Germany! Al/Alu!Blister!

3*1,!3*25,6*1,!6*25!

Amodiaquin(as!Hydrochloride)+Artesunate!(FDC)!

270!mg!+100!mg! Tablet! IPCA!Laboratories!Ltd! A! Yes! Dadra!and!Nagar!Haveli,! India! Al/Alu!Blister!10x1x3;!10x1x6;!25x3;!25x6!

Amodiaquin(as!Hydrochloride)+Artesunate!(FDC)!

270!mg!+100!mg! Tablet!Guilin!Pharmaceutical!Co.!Ltd! A! Yes! Guilin,!Guangxi,!China! China!

Alu/PA/Alu/PVC!blister! 3,!6!

Artesunate!+!Mefloquine!(CoABlistered)! 200!mg!+!250!mg! Tablet! Mepha! B! Yes! Dornacherstrasse,!Aesch! Switzerland! CoAblister! 3+6!

Artesunate+!Mefloquin!(as!Hydrochloride)!(FDC)! 25mg+50mg! Tablet! Cipla!Ltd.! A! Yes! Patalganga! India! Alu/Alu!strip! 1x3,!2x3!

Artesunate+!Mefloquin!(as!Hydrochloride)!(FDC)! 100mg+200mg! Tablet! Cipla!Ltd.! A! Yes! Patalganga! India! Alu/Alu!strip! 1x3,!2x3!

Artesunate!+!(Sulfadoxine+Pyrimethamine)!Co!Blistered!

50mg+!(500mg+25mg)!

Tablet!CoAblister! Guilin!Pharmaceuticals! A! Yes! Guilin,!Guangxi! China! PVC/Alu!Blister! (3+1),!(6+2)!

Piperaquine!tetraphosphate!(as!the!tetrahydrate;!PQP)!+!Dihydroartemisinin!(DHA)!

160mg+20mg! Tablet! SigmaAtau!Industrie! B! Yes! Pomezia! Italy!PVC/PVdC/Alu!blister! 3!

Piperaquine!tetraphosphate!(as!the!tetrahydrate;!PQP)!+!Dihydroartemisinin!(DHA)!

320mg+!40mg! Tablet! SigmaAtau!Industrie! B! Yes! Pomezia! Italy!PVC/PVdC/Alu!blister! 3!

Page 31: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 27!

Annex%2:%2013%Outlet%Survey%Activities%and%Schedule%%June%2013:!Research!protocol!design!July%2013:!Study!and!training!preparation,!preAtesting!questionnaire,!pilot!test!August%2013:!Study!and!training!preparation!and!training!of!field!team!September/October%2013:!Data!collection!September/October%2013:%Data!entry%November%2013:!!Data!submission!to!ACTwatch!

!

Description%Jun! Jul! Aug! Sep! Oct! Nov!

W1! W2! W3! W4! W1! W2! W3! W4! W1! W2! W3! W4! W1! W2! W3! W4! W1! W1! W3! W4! W1!Research!protocol!design! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !!Study!&!training!preparation! !! !! !! !! !! !! ! ! ! ! !! !! !! !! !! !! !! !! !! !! !!Training!of!the!field!team! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !!PreAtesting!the!questionnaire!! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !

Pilot!Test! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! !Data!Collection!! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !!Data!Entry!!! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !!Data!Submission!to!ACTwatch! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !! !!

Page 32: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 28!

Annex%3:%%Outlet%Survey%Questionnaire%

!! !

Page 33: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 29!

ACTwatch%Outlet%Survey% CAMBODIA%2013%%Section%I:%Census%Information%Interviewer)completes)this)section)for)all)outlets.%

%%%Outlet%ID%Interviewer-District-Commune-Outlet!ID!! [___|___]-[___|___]-[___|___|___]-[___|___|___]!C1.!Today’s!date!(dd/mm/yyyy)!

!![___|___]-[___|___]-[_2_|_0_|_1_|_3_]!C2.!Interviewer’s!name!!

[__________________________________________________________________]!

C2a.!Interviewer’s!code!!

! [___|___]!C3.!District!

!

[__________________________________________________________________]!

C3a.!District!code!!

! [___|___]!C4.!Commune!

!

[__________________________________________________________________]!

C4a.!Commune!code!!

! [___|___|___]!C5.!Village!

!

[__________________________________________________________________]!!C6.!Name!of!outlet! If)no)name,)record)“no)name”)or)owner’s)name!

!

[__________________________________________________________________]!C6a.!Outlet!code!

!

! [___|___|___]!C7.!Type!of!Outlet! !01! Referral!Hospital! 08!!!!Private!Hospital! 16!!!!Village!Shop! !

02! Health!Center! 09!!!!Private!Clinic/Poly!Clinic! 17!!!!Mobile!Provider!-!only!mobile! !

03! Former!District!Hospital! 10!!!!Clinical!Pharmacy/Pharmacy! 18!!!!Mobile!Provider!-!fixed!clinic/base!+!mobile! !04! Health!Post! 11!!!!Depot!A! 19! Private!diagnostic!lab!(lab!only)! [___|___]!05! Village!Malaria!worker!/!Mobile!!!!!!!!!!!Malaria!worker!

12!!!!Depot!B!13!!!!Cabinet!

20! NGO/mission!diagnostic!lab!(lab!only)!

!96!!!!Other!(specify):)!!!!!!!![__________________________]!!!!!!!!!!

06!!!!NGO/Mission!Faith-based!Hospital!! 14!!!!Drug!Store! !07!!!!NGO/Mission!Faith-based!!Clinic!! 15!!!!Grocery!Store!

!

C8.!Is!this!commune!part!of!the!booster!sample?! 1!!=!!Yes! 0!!=!!No!! [___]!!

Hello,!my! name! is! __________,! I!work! on! behalf! of! Population! Services! International! (PSI).!We! are! conducting! a! study! on! the! availability! of!antimalarial!medicines!and!diagnostic!testing!services.!The!results!will!be!used!to!improve!the!availability!of!appropriate!antimalarial!treatment!in!Cambodia.!I!would!like!to!ask!you!a!few!questions!to!see!if!you!could!be!part!of!the!survey.!

!

Screening)questions!S1.!Do!you!have!any!medicines!in!stock!today?!

1!=!Yes! ! go)to)S3!0!=!No!

[___]!

S2.!Are!there!any!medicines!that!are!out!of!stock!today,!but!that!you!stocked!in!the!past%3%months?%1!=!Yes! ! go)to)S4)0!=!No! ! go)to)S5)8!=!Don’t!know! go)to)S5)

[___]!

S3.!Do!you!have!any!antimalarial!medicines!in!stock!today?!1!=!Yes! ! ! provide)information)sheet)&)gain)consent.)Record)start)time)in)C9.)

) Proceed)to)Section)II:)Antimalarial)Audit.)0!=!No! ! go)to)S4)

[___]!

S4.!Are!there!any!antimalarial!medicines!that!are!out!of!stock!today,!but!that!you!stocked!in!the!past%3%months?%1!=!Yes! ! ! provide)information)sheet)&)gain)consent.)Record)start)time)in)C9.)Proceed)to)A13.!0!=!No! ! ! verify)with)prompt)card.)Go)to)S5)8!=!Don’t!know! verify)with)prompt)card.)Go)to)S5!

[___]!

S5.!Are!you!offering!any!diagnostic!services!or!selling!any!diagnostic!tests!here!today?!1!=!Yes! ! go)to)S6!0!=!No! ! verify)with)prompt)card.)Record)details)in)C9)then)complete)Sec)X:)Ending)interview)

[___]!

S6.!Are!any!of!these!services!or!tests!for!suspected!malaria?!1!=!Yes! ! ! provide)information)sheet)&)gain)consent.)Record)start)time)in)C9.)

) Proceed)to)Section)III:)Diagnostic)Audit))0!=!No! ! verify)with)prompt)card.)Record)details)in)C9)then)complete)Sec)X:)Ending)interview!

[___]!

Before)proceeding)to)the)full)interview)ensure)you)have)given)the)respondent)a)study)information)sheet,)explained)the)study)and)obtained)informed)consent.

Page 34: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 30!

C9.!Result!of!Visit(s)!!

Date!(dd/mm/yy)!

Visit%1% Visit%2% Visit%3%

[___|___]-[___|___]-[_1_|_3_]! [___|___]-[___|___]-[_1_|_3_]! [___|___]-[___|___]-[_1_|_3_]!Time!started!

(use)24hr)clock))95:95)=)Not)applicable [___|___]:[___|___] [___|___]:[___|___] [___|___]:[___|___]

Time!completed!(use)24hr)clock))

95:95)=)Not)applicable! [___|___]:[___|___] [___|___]:[___|___] [___|___]:[___|___] !

Result! [___|___]! [___|___]! [___|___]!01!=!Completed!interview! ! go)to)E1)02!=!Outlet!does!not!meet!any!screening!criteria!!go)to)E1!03!=!Interview!interrupted! ! go)to)C11)04!=!Eligible!respondent!not!available!/!Time!not!convenient!!go)to)C11)05!=!Outlet!not!open!at!the!time! go)to)C11)06!=!Outlet!closed!permanently!! go)to)E1)96!=!Other!(specify):%[____________________________________________________________________________]!97!=!Refused!! ! go)to)C10)

C10.!If!the!provider!refused,!why?!!

1!!=!!Client!load! Ask)respondent)for)a)time)they)would)prefer)to)be)interviewed)and)note)in)C11)2!!=!!Thinks!it’s!an!inspection!/!nervous!about!license! go)to)E1)3!!=!!Not!interested! ! go)to)E1)6!!=!!Other!(specify):![__________________________________________________________________________________]!7!!=!!Refuses!to!give!reason! go)to)E1)

[___]!

C11.!Use)this)space)to)record)call)back)details.)If)it)is)not)possible)to)complete)the)interview)at)another)time,)go)to)E1.)!!%

%

THANK)THE)PROVIDER)AND)END)INTERVIEW

Section%IX:%Other%medicines%Interviewer:)In!outlets!without%medicines!in!stock!today,!skip!to!Section%X:%Ending%the%interview!X1.!Do!you!have!any!of!the!following!products!in!stock!today?!

Ask)provider)to)show)an)example)of)each)product)if)it)is)in)stock)today.)Only)record)‘1’)if)product)type)has)been)observed.)!

1!=!observed!the!product!in!stock!today!0!=!product!not!in!stock!today!8!=!respondent!doesn’t!know!if!product!in!stock!today!!

I.! Oral!Rehydration!Salt,!also!called!ORS!or!ORT! [___] II.! Zinc!tablets! [___]

Section%X:%Ending%the%interview!

E1.!Name!of!interviewee:! [_____________________________________________________]!!

! ! ! ! 5!=!Not!applicable,!no!respondent;!7!=!Refused!!!!!!!!!!!!!!!!!!![___]!

E2.!Physical!address!or!location!identifiers!of!outlet!(not!PO!box)!(Give)detailed)description)that)will)help)supervisor)to)find)the)outlet))

!!

E3.!Telephone!number!9999999995!=!Not!applicable:!no!respondent!

or!has!no!telephone!9999999997!=!Refused!

![___|___|___|___|___|___|___|___|___|___]!

E4.Latitude:! [_N_]-[___|___|___]-[___|___|___|___|___]! E5.Longitude:! [_E_]-[___|___|___]-[___|___|___|___|___]!E7.!Additional%observations%by%interviewer%(if%any)%

!

Page 35: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

3!

Section%II:%Antimalarial%Audit%!A0.)Read)to)the)provider:)Can!you!please!show!us!the!full!range!of!antimalarials!that!you!currently!have!in!stock?!Do!you!currently!have!any!of!the!following?!Prompt)entire)list)using)antimalarial)prompt)card;)No)response)to)be)recorded.))

• Artemisinin!combination!therapies,!such!as:!

• !A+M1,!A+M2,!A+M3,!A+M4,!A+M5!

• Malarine!

• Duo4cotecxin!

• Other!ACTs!including!Artekin,!Artequick,!Artecan,!Noriafen,!Co4artesiane,!Co4arinate,!Arterakine,!ARCO!

• Artemisinin!monotherapies,!such!as!Arinate,!Arquine,!Plasmotrim,!Artesunate,!Santecxin,!Cotecxin,!Arsumax,!Prevention4A,!Artemedine!

• Quinine,!such!as!Anoginquinin,!Quinine!dihydrochloride,!Quinine!sulphate!(+Tetracyclin)!

• Mefloquine,!such!as!Mefloquine,!Mephaquin,!Larium!

• Chloroquine,!such!as!Chloroquine!phosphate,!Nitaquine,!Nivaquine,!HCQ!200!

• Syrups!or!suspensions!-!Cotecxin!Pediatrique!

• Injectables,!such!as!Sanarteme,!Artemedine,!Artesiane,!Artemether,!Quinine!Dihydrochloride,!Malacin,!Artesunate!(powder)!

• Granules!or!powders,!such!as!Artequick,!Artesunate!)If)the)outlet)has)no)antimalarials)in)stock)crossacheck)screening)results)then)proceed)to)question)A13.!!Proceed)to)the)antimalarial)audit.)Different)antimalarial)audit)sheets)will)be)used)to)record)the)antimalarial)information)based)on)the)dosage)form)of)the)medicine.))Separate)the)antimalarials)into)two)piles:)

• The)first)pile)should)contain)all)the)antimalarials)in)the)form)of)tablets,)suppositories,)or)granules.)Use)the)Tablets,)Suppositories)&)Granules)Drug)Audit)Sheet)to)record)these.))

• The)second)pile)should)contain)all)the)antimalarials)in)any)form)other)than)tablets,)suppositories)or)granules.)Use)the)NonaTablet)Drug)Audit)Sheet)to)record)these.)!

If)additional)audit)sheets)are)used,)add)these)sheets)after)the)ones)provided)and)staple)the)questionnaire)again.)All)pages)should)be)in)order)before)you)move)onto)the)next)outlet.))Number)each)drug)by)assigning)a)Product)Number.)Number)each)audit)sheet)used)in)the)spaces)provided)at)the)bottom)of)the)page.))ADDITIONAL)NOTES)FOR)HEALTH)FACILITIES))

In)health)facilities)complete)the)Dispensary)/)Clinic)Code)as)well)as)the)Product)Number)for)each)drug)audited.)Dispensary)/)Clinic)codes)are)listed)below.)!

)Dispensary)/)Clinic)Codes!

A! Outpatient!department!/!dispensary!(if!used!by!all!patients)!

B! Adult!outpatient!department!/!adult!dispensary!/!adult!clinic!

C! Child!outpatient!department!/!child!dispensary!/!child!clinic!

D! Antenatal!/!maternity!clinic!

E! ART!/!HIV/AIDS!clinic!

G! Private!dispensing!unit!within!a!public!hospital!

L! Laboratory!(for)RDT)audit))

Z! Comprehensive!Clinic!/!Other!(note)type)in)audit)comments))

Page 36: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

TABLET, SUPPOSITORY & GRANULE DRUG AUDIT SHEET (TSG)OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 32!

!

Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

!

![__|__]!

![__|__]!

![__|__]!

1.&Generic&name&!!!!!!!

2.&Strength!![__|__|__].[__]mg!![__|__|__].[__]mg!![__|__|__].[__]mg!

2a.&Is&this&base&strength?&

!

!![__]!!!!!!!!!!!!!!1!=!Yes!!![__]!!!0!=!No!!!!!!!!!!!!!!!8!=!Don’t!know!

!![__]!If!no,!specify!salt:!![______________]!

3.&Dosage&form&!1!=!Tablet!

2!=!Suppository!

3!=!Granule!

![___]!

4.&Brand&name! 5.&Manufacturer&&

6.&Country&of&manufacture&Do!not!write!here!

7.&Package&size&!

There!are!a!total!of!!

[___|___|___|___]!tablets/!suppositories/!granule!packs!in!each:!!

1!=!Package!2!=!Pot/tin!

!

!!!!!!!!!!!!!![___]&[__|__]! [__|__|__]!8.&Is&product&a&fixedJdose&combination&(FDC)&&1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!!know&&&

[___]!

9.&Does&product&have&the&AMFm&logo?&&1!=!Yes!0!=!No&&&&

[___]&

10.&Amount&sold/distributed&in&the&last&7&days&to&individual&consumers&(Record'#'of'packages'/'tins'described'in'Q7!OR'record'the'total'#'of'tablets'/'suppositories'/'granule'packs'sold)!!This!outlet!sold![___|___|___|___]!packages/&tins!in!the!last!7!days!! OR!This!outlet!sold![___|___|___|___]!tablets/&suppositories&or&granule&packs!in!the!last!7!days!!

Not!applicable!=!9995;!Refused!=!9997;!Don’t!know!=!9998!

10a.&Stocked&out&at&any&point&in&the&past&2&weeks?&!1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

!!!!!!!![___]!

10b.&Stocked&out&at&any&point&in&the&past&3&months?&!1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

[___]&

10c.&Stocked&out&for&at&least&one&week&in&the&past&3&months?&&1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

!!!!!!!![___]&

11.&Retail&selling&price&!

![___|___|___]!tablets,&suppositories&or&granule&packs!cost!an!individual!customer!![___|___|___|___|___|___]!Riel&

12.&Wholesale&purchase&price&For!the!outlet’s!most!recent!wholesale!purchase!!![___|___|___|___]!tablets,&suppositories&or&granule&packs!cost!!![___|___|___|___|___|___]!Riel&

13.&Comments&

Free!=!000000;!Refused!=!999997;Don’t!know!=!999998&!Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

!

![__|__]!

![__|__]!

![__|__]!

1.&Generic&name&!!!!!!!

2.&Strength!![__|__|__].[__]mg!![__|__|__].[__]mg!![__|__|__].[__]mg!

2a.&Is&this&base&strength?&

!

!![__]!!!!!!!!!!!!!!1!=!Yes!!![__]!!!0!=!No!!!!!!!!!!!!!!!8!=!Don’t!know!

!![__]!If!no,!specify!salt:!![______________]!

3.&Dosage&form&!1!=!Tablet!

2!=!Suppository!

3!=!Granule!

![___]!

4.&Brand&name! 5.&Manufacturer&&

6.&Country&of&manufacture&Do!not!write!here!

7.&Package&size&!

There!are!a!total!of!!

[___|___|___|___]!tablets/!suppositories/!granule!packs!in!each:!!

1!=!Package!2!=!Pot/tin!

!

!!!!!!!!!!!!!![___]&[__|__]! [__|__|__]!8.&Is&product&a&fixedJdose&combination&(FDC)&&1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!!know&&&

[___]!

9.&Does&product&have&the&AMFm&logo?&&1!=!Yes!0!=!No&&&&

[___]&

10.&Amount&sold/distributed&in&the&last&7&days&to&individual&consumers&(Record'#'of'packages'/'tins'described'in'Q7!OR'record'the'total'#'of'tablets'/'suppositories'/'granule'packs'sold)!!This!outlet!sold![___|___|___|___]!packages/&tins!in!the!last!7!days!! OR!This!outlet!sold![___|___|___|___]!tablets/&suppositories&or&granule&packs!in!the!last!7!days!!

Not!applicable!=!9995;!Refused!=!9997;!Don’t!know!=!9998!

10a.&Stocked&out&at&any&point&in&the&past&2&weeks?&!1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

!!!!!!!![___]!

10b.&Stocked&out&at&any&point&in&the&past&3&months?&!1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

[___]&

10c.&Stocked&out&for&at&least&one&week&in&the&past&3&months?&&1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

!!!!!!!![___]&

11.&Retail&selling&price&!

![___|___|___]!tablets,&suppositories&or&granule&packs!cost!an!individual!customer!![___|___|___|___|___|___]!Riel&

12.&Wholesale&purchase&price&For!the!outlet’s!most!recent!wholesale!purchase!!![___|___|___|___]!tablets,&suppositories&or&granule&packs!cost!!![___|___|___|___|___|___]!Riel&

13.&Comments&

Free!=!000000;!Refused!=!999997;Don’t!know!=!999998&

Tablet!Audit!Sheet![__|__]!of![__|__]! !

Page 37: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

TABLET, SUPPOSITORY & GRANULE DRUG AUDIT SHEET (TSG)OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 33!

!Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

!

![__|__]!

![__|__]!

![__|__]!

1.&Generic&name&!!!!!!!

2.&Strength!![__|__|__].[__]mg!![__|__|__].[__]mg!![__|__|__].[__]mg!

2a.&Is&this&base&strength?&

!

!![__]!!!!!!!!!!!!!!1!=!Yes!!![__]!!!0!=!No!!!!!!!!!!!!!!8!=!Don’t!know!!![__]!If!no,!specify!salt:!![______________]!

3.&Dosage&form&!1!=!Tablet!

2!=!Suppository!

3!=!Granule!

![___]!

4.&Brand&name! 5.&Manufacturer&&

6.&Country&of&manufacture&Do!not!write!here!

7.&Package&size&!

There!are!a!total!of!!

[___|___|___|___]!tablets/!suppositories/!granule!packs!in!each:!!

1!=!Package!2!=!Pot/tin!

!

!!!!!!!!!!!!!![___]&[__|__]! [__|__|__]!8.&Is&product&a&fixedJdose&combination&(FDC)&&1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!!know&&&

[___]!

9.&Does&product&have&the&AMFm&logo?&&1!=!Yes!0!=!No&&&&

[___]&

10.&Amount&sold/distributed&in&the&last&7&days&to&individual&consumers&(Record'#'of'packages'/'tins'described'in'Q7!OR'record'the'total'#'of'tablets'/'suppositories'/'granule'packs'sold)!!This!outlet!sold![___|___|___|___]!packages/&tins!in!the!last!7!days!! OR!This!outlet!sold![___|___|___|___]!tablets/&suppositories&or&granule&packs!in!the!last!7!days!&

Not!applicable!=!9995;!Refused!=!9997;!Don’t!know!=!9998!

10a.&Stocked&out&at&any&point&in&the&past&2&weeks?&!1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

!!!!!!!![___]!

10b.&Stocked&out&at&any&point&in&the&past&3&months?&!1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

[___]&

10c.&Stocked&out&for&at&least&one&week&in&the&past&3&months?&&1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

!!!!!!!![___]&

11.&Retail&selling&price&!

![___|___|___]!tablets,&suppositories&or&granule&packs!cost!an!individual!customer!![___|___|___|___|___|___]!Riel&

12.&Wholesale&purchase&price&For!the!outlet’s!most!recent!wholesale!purchase!!![___|___|___|___]!tablets,&suppositories&or&granule&packs!cost!!![___|___|___|___|___|___]!Riel&

13.&Comments&

Free!=!000000;!Refused!=!999997;Don’t!know!=!999998&!Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

!

![__|__]!

![__|__]!

![__|__]!

1.&Generic&name&!!!!!!!

2.&Strength!![__|__|__].[__]mg!![__|__|__].[__]mg!![__|__|__].[__]mg!

2a.&Is&this&base&strength?&

!

!![__]!!!!!!!!!!!!!!1!=!Yes!!![__]!!!0!=!No!!!!!!!!!!!!!!8!=!Don’t!know!!![__]!If!no,!specify!salt:!![______________]!

3.&Dosage&form&!1!=!Tablet!

2!=!Suppository!

3!=!Granule!

![___]!

4.&Brand&name! 5.&Manufacturer&&

6.&Country&of&manufacture&Do!not!write!here!

7.&Package&size&!

There!are!a!total!of!!

[___|___|___|___]!tablets/!suppositories/!granule!packs!in!each:!!

1!=!Package!2!=!Pot/tin!

!

!!!!!!!!!!!!!![___]&[__|__]! [__|__|__]!8.&Is&product&a&fixedJdose&combination&(FDC)&&1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!!know&&&

[___]!

9.&Does&product&have&the&AMFm&logo?&&1!=!Yes!0!=!No&&&&

[___]&

10.&Amount&sold/distributed&in&the&last&7&days&to&individual&consumers&(Record'#'of'packages'/'tins'described'in'Q7!OR'record'the'total'#'of'tablets'/'suppositories'/'granule'packs'sold)!!This!outlet!sold![___|___|___|___]!packages/&tins!in!the!last!7!days!! OR!This!outlet!sold![___|___|___|___]!tablets/&suppositories&or&granule&packs!in!the!last!7!days!&

Not!applicable!=!9995;!Refused!=!9997;!Don’t!know!=!9998!

10a.&Stocked&out&at&any&point&in&the&past&2&weeks?&!1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

!!!!!!!![___]!

10b.&Stocked&out&at&any&point&in&the&past&3&months?&!1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

[___]&

10c.&Stocked&out&for&at&least&one&week&in&the&past&3&months?&&1!=!Yes!0!=!No!8!=!Don’t!!!!!!!!know!&

!!!!!!!![___]&

11.&Retail&selling&price&!

![___|___|___]!tablets,&suppositories&or&granule&packs!cost!an!individual!customer!![___|___|___|___|___|___]!Riel&

12.&Wholesale&purchase&price&For!the!outlet’s!most!recent!wholesale!purchase!!![___|___|___|___]!tablets,&suppositories&or&granule&packs!cost!!![___|___|___|___|___|___]!Riel&

13.&Comments&

Free!=!000000;!Refused!=!999997;Don’t!know!=!999998&

Tablet!Audit!Sheet![__|__]!of![__|__]!

Page 38: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

NON-TABLET DRUG AUDIT SHEET (NT): SYRUP, SUSPENSION, INJECTIONS & OTHERS OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

7!

!

Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

!!

[__|__]!!

[__|__]!!

[__|__]!

1.&Generic&name&!!

!!!!!

2.&Strength'&[__|__|__|__].[__]mg/[__|__|__].[__]mL!![__|__|__|__].[__]mg/[__|__|__].[__]mL!![__|__|__|__].[__]mg/[__|__|__].[__]mL!!(Note:'no'mL'recorded'for'powder'injection)!

2a.&Is&this&base&strength?&!

!![__]!!!!!!!!!!!!!1!=!Yes!!![__]!!0!=!No!!!!!!!!!!!!!!8!=!Don’t!know!!![__]!If!no,!specify!salt:!!![_______________]!

3.&Dosage&form&!

1!=!Syrup!2!=!Suspension!3!=!Liquid!inj.!4!=!Powder!inj.!5!=!Drops!6!=!Other!(specify)!

!! [___]!

4.&Brand&name! 5.&Manufacturer&!

6.&Country&of&Manufacturer&

![__|__]! [__|__|__]!

7.&Package&size&!There!are!a!total!of!!![___|___|___|___].[__]!mL!(or!mg!for!powder!injections)!in!each:!

1!=!Bottle!2!=!Ampoule/vial!

![___]&

9.&Does&this&product&have&the&AMFm&logo?&&1!=!Yes!0!=!No&&

&[___]&

10.&Amount&sold/&distributed&in&the&last&7&days&to&individual&consumers&!

This!outlet!sold!!!

[___|___|___|___]!bottles,&ampoules&or&vials!in!the!last!7!days!!

Refused!=!9997;!Don’t!know!=!9998!

10a.&Stocked&out&at&any&point&in&the&past&2&weeks?&!!

1!=!Yes!0!=!No!8!=!Don’t!!

!know&!

!!!!!!![___]!

10b.&Stocked&out&at&any&point&in&the&past&3&months?&!!

1!=!Yes!0!=!No!8!=!Don’t!

!know&!

!!!!!!!![___]&

10c.&Stocked&out&for&at&least&one&week&in&the&past&3&months?&!!

1!=!Yes!0!=!No!8!=!Don’t!

!know&!

!!!!!!![___]&

11.&Retail&selling&price&&&&[___|___]!bottles&ampoules&or&vials!cost!an!individual!customer!![___|___|___|___|___|___]!Riel'

12.&Wholesale&purchase&price&For!the!outlet’s!most!recent!wholesale!purchase:!![___|___|___|___]!bottles,&ampoules&or&vials!cost!![___|___|___|___|___|___]!Riel!

13.&Comments&

Free!=!000000;!Refused!=!999997;Don’t!know!=!999998&!

Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

!!

[__|__]!!

[__|__]!!

[__|__]!

1.&Generic&name&!!

!!!!!

2.&Strength'&[__|__|__|__].[__]mg/[__|__|__].[__]mL!![__|__|__|__].[__]mg/[__|__|__].[__]mL!![__|__|__|__].[__]mg/[__|__|__].[__]mL!!(Note:'no'mL'recorded'for'powder'injection)!

2a.&Is&this&base&strength?&!

!![__]!!!!!!!!!!!!!1!=!Yes!!![__]!!0!=!No!!!!!!!!!!!!!!8!=!Don’t!know!!![__]!If!no,!specify!salt:!!![_______________]!

3.&Dosage&form&!

1!=!Syrup!2!=!Suspension!3!=!Liquid!inj.!4!=!Powder!inj.!5!=!Drops!6!=!Other!(specify)!

!! [___]!

4.&Brand&name! 5.&Manufacturer&!

6.&Country&of&Manufacturer&

![__|__]! [__|__|__]!

7.&Package&size&!There!are!a!total!of!!![___|___|___|___].[__]!mL!(or!mg!for!powder!injections)!in!each:!

1!=!Bottle!2!=!Ampoule/vial!

![___]&

9.&Does&this&product&have&the&AMFm&logo?&&1!=!Yes!0!=!No&&

&[___]&

10.&Amount&sold/&distributed&in&the&last&7&days&to&individual&consumers&!

This!outlet!sold!!!

[___|___|___|___]!bottles,&ampoules&or&vials!in!the!last!7!days!!

Refused!=!9997;!Don’t!know!=!9998!

10a.&Stocked&out&at&any&point&in&the&past&2&weeks?&!!

1!=!Yes!0!=!No!8!=!Don’t!!

!know&!

!!!!!!![___]!

10b.&Stocked&out&at&any&point&in&the&past&3&months?&!!

1!=!Yes!0!=!No!8!=!Don’t!

!know&!

!!!!!!!![___]&

10c.&Stocked&out&for&at&least&one&week&in&the&past&3&months?&!!

1!=!Yes!0!=!No!8!=!Don’t!

!know&!

!!!!!!![___]&

11.&Retail&selling&price&&&&[___|___]!bottles&ampoules&or&vials!cost!an!individual!customer!![___|___|___|___|___|___]!Riel'

12.&Wholesale&purchase&price&For!the!outlet’s!most!recent!wholesale!purchase:!![___|___|___|___]!bottles,&ampoules&or&vials!cost!![___|___|___|___|___|___]!Riel!

13.&Comments&

!

Non\Tablet!Audit!Sheet![___|___]!of![___|___]! !

Page 39: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

NON-TABLET DRUG AUDIT SHEET (NT): SYRUP, SUSPENSION, INJECTIONS & OTHERS OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 35!

!

Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

!!

[__|__]!!

[__|__]!!

[__|__]!

1.&Generic&name&!!

!!!!!

2.&Strength'&[__|__|__|__].[__]mg/[__|__|__].[__]mL!![__|__|__|__].[__]mg/[__|__|__].[__]mL!![__|__|__|__].[__]mg/[__|__|__].[__]mL!!(Note:'no'mL'recorded'for'powder'injection)!

2a.&Is&this&base&strength?&!

!![__]!!!!!!!!!!!!!1!=!Yes!!![__]!!0!=!No!!!!!!!!!!!!!!8!=!Don’t!know!!![__]!If!no,!specify!salt:!!![_______________]!

3.&Dosage&form&!

1!=!Syrup!2!=!Suspension!3!=!Liquid!inj.!4!=!Powder!inj.!5!=!Drops!6!=!Other!(specify)!

!! [___]!

4.&Brand&name! 5.&Manufacturer&!

6.&Country&of&Manufacturer&

![__|__]! [__|__|__]!

7.&Package&size&!There!are!a!total!of!!![___|___|___|___].[__]!mL!(or!mg!for!powder!injections)!in!each:!

1!=!Bottle!2!=!Ampoule/vial!

![___]&

9.&Does&this&product&have&the&AMFm&logo?&&1!=!Yes!0!=!No&&

&[___]&

10.&Amount&sold/&distributed&in&the&last&7&days&to&individual&consumers&!

This!outlet!sold!!!

[___|___|___|___]!bottles,&ampoules&or&vials!in!the!last!7!days!!

Refused!=!9997;!Don’t!know!=!9998!

10a.&Stocked&out&at&any&point&in&the&past&2&weeks?&!!

1!=!Yes!0!=!No!8!=!Don’t!!

!know&!

!!!!!!![___]!

10b.&Stocked&out&at&any&point&in&the&past&3&months?&!!

1!=!Yes!0!=!No!8!=!Don’t!

!know&!

!!!!!!!![___]&

10c.&Stocked&out&for&at&least&one&week&in&the&past&3&months?&!!

1!=!Yes!0!=!No!8!=!Don’t!

!know&!

!!!!!!![___]&

11.&Retail&selling&price&&&&[___|___]!bottles&ampoules&or&vials!cost!an!individual!customer!![___|___|___|___|___|___]!Riel'

12.&Wholesale&purchase&price&For!the!outlet’s!most!recent!wholesale!purchase:!![___|___|___|___]!bottles,&ampoules&or&vials!cost!![___|___|___|___|___|___]!Riel!

13.&Comments&

!

Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

!!

[__|__]!!

[__|__]!!

[__|__]!

1.&Generic&name&!!

!!!!!

2.&Strength'&[__|__|__|__].[__]mg/[__|__|__].[__]mL!![__|__|__|__].[__]mg/[__|__|__].[__]mL!![__|__|__|__].[__]mg/[__|__|__].[__]mL!!(Note:'no'mL'recorded'for'powder'injection)!

2a.&Is&this&base&strength?&!

!![__]!!!!!!!!!!!!!1!=!Yes!!![__]!!0!=!No!!!!!!!!!!!!!!8!=!Don’t!know!!![__]!If!no,!specify!salt:!!![_______________]!

3.&Dosage&form&!

1!=!Syrup!2!=!Suspension!3!=!Liquid!inj.!4!=!Powder!inj.!5!=!Drops!6!=!Other!(specify)!

!! [___]!

4.&Brand&name! 5.&Manufacturer&!

6.&Country&of&Manufacturer&

![__|__]! [__|__|__]!

7.&Package&size&!There!are!a!total!of!!![___|___|___|___].[__]!mL!(or!mg!for!powder!injections)!in!each:!

1!=!Bottle!2!=!Ampoule/vial!

![___]&

9.&Does&this&product&have&the&AMFm&logo?&&1!=!Yes!0!=!No&&

&[___]&

10.&Amount&sold/&distributed&in&the&last&7&days&to&individual&consumers&!

This!outlet!sold!!!

[___|___|___|___]!bottles,&ampoules&or&vials!in!the!last!7!days!!

Refused!=!9997;!Don’t!know!=!9998!

10a.&Stocked&out&at&any&point&in&the&past&2&weeks?&!!

1!=!Yes!0!=!No!8!=!Don’t!!

!know&!

!!!!!!![___]!

10b.&Stocked&out&at&any&point&in&the&past&3&months?&!!

1!=!Yes!0!=!No!8!=!Don’t!

!know&!

!!!!!!!![___]&

10c.&Stocked&out&for&at&least&one&week&in&the&past&3&months?&!!

1!=!Yes!0!=!No!8!=!Don’t!

!know&!

!!!!!!![___]&

11.&Retail&selling&price&&&&[___|___]!bottles&ampoules&or&vials!cost!an!individual!customer!![___|___|___|___|___|___]!Riel'

12.&Wholesale&purchase&price&For!the!outlet’s!most!recent!wholesale!purchase:!![___|___|___|___]!bottles,&ampoules&or&vials!cost!![___|___|___|___|___|___]!Riel!

13.&Comments&

!

Non\Tablet!Audit!Sheet![___|___]!of![___|___]Non\Tablet!Audit!Sheet![___|___]!of![___|___]!

Page 40: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 36!

Antimalarial!stock!outs!A13.!Are!there!any!antimalarial!medicines!that!are!out!of!stock!today,!but!that!you!stocked!in!the!!!!!!!!!!past!2"weeks?!!

1!=!Yes!0!=!No! ! go#to#A15!8!=!Don’t!know! go#to#A15!

[___]!

A14.!Do!you!know!the!names!of!the!treatments!that!are!out!of!stock?!Will#accept#generic#or#brand#names.#Record#one#medicine#per#line.!!

1!!=!!Yes,!specify# 0!=!No"

[_____________________________________]!!!!!![_____________________________________]!

[_____________________________________]!!!!!![_____________________________________]!

[_____________________________________]!!!!!![_____________________________________]!

[_____________________________________]!!!!!![_____________________________________]!

[_____________________________________]!!!!!![_____________________________________]!

[___]!

A15.!Are!there!any!antimalarial!medicines!that!are!out!of!stock!today,!but!that!you!stocked!in!the!!!!!!!!!!past!3"months?"!

1!=!Yes! ! !0!=!No! ! go#to#A18!8!=!Don’t!know! go#to#A18!

[___]!

A16.!Do!you!know!the!names!of!the!treatments!that!are!out!of!stock?!Will#accept#generic#or#brand#names.#Record#one#medicine#per#line.!!

1!!=!!Yes,!specify# 0!=!No"

[_____________________________________]!!!!!![_____________________________________]!

[_____________________________________]!!!!!![_____________________________________]!

[_____________________________________]!!!!!![_____________________________________]!

[_____________________________________]!!!!!![_____________________________________]!

[_____________________________________]!!!!!![_____________________________________]!

[___]!

A17.!!Have!the!following!antimalarials!that!are!currently!out!of!stock!been!out!of!stock!for!1!week!or!longer!at!any!point!in!the!last!three!months?!

#

Read#list.!Antimalarials#that#have#not#been#recorded#on#the#audit#sheets#are#currently#out#of#stock.##

I.! ! ! ! A+M1!

II.! ! ! ! A+M2!

III.!! ! ! ! A+M3!

IV.!! ! ! ! A+M4!

V.!! ! ! ! A+M5!

VI.!! ! !!!!!!!!Malarine!for!Adults!

VII.!! ! !Malarine!for!Teenagers!

VIII.!! ! !!!!!Malarine!for!Children!

IX.! !!!!!!!!!!!!!!Eurartesim!Child!7V23!kgs!

X.! !!!!!!!!!!!!Eurartesim!Child!24V35!kgs!

XII.! !!!!!!!!!!!Eurartesim!Adult!36V74!kgs!

XIII.!! ! DuoVCotecxin!for!Adults!

XIV.!!DuoVCotecxin!for!Adults!and!Children!

1!=!Yes!0!=!No!8!=!Don’t!know!5!=!Not!applicable!!!!!!!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

Page 41: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 37!

A18.!Does!this!outlet!provide!‘Tnam#psom’#for!malaria?!!

1!=!Yes!0!=!No! ! go#to#Section#III:#Diagnostic#Audit!!8!=!Don’t!know! go#to#Section#III:#Diagnostic#Audit!

!

[___]!

A19.!In!this!outlet!are!‘Tnam#psom’#for!malaria:!Read#list.#Record#only#one#response.!!

1!=!PreVmade!2!=!Prepared!at!the!time!customers!come!for!treatment#go#to#A21!3!=!Both!!

[___]!

A20.!Where!do!you!obtain!these!‘Tnam#psom’#for!malaria?!!Interviewer#read#out#responses.#Multiple#responses#possible.#!

! ! I.!!!!!! !! ! !!!!!!!!!Other!providers!!

! !!!!!!!!!!!!!!! II.! ! !! ! !!!!!!!!!!!!!!!!!!Wholesaler!

!!!!III.! ! Made!in!this!outlet!IV.!Other!(specify)#[__________________________]#

!

!!

[___]!

[___]!

[___]!

[___]!

A21.!Please!show!me!the!‘Tnam!psom’!you!sell,!or!that!you!would!prepare!to!sell,!for!adult!man!with!symptoms!of!malaria.!!!(Interviewer#to#observe#what#the#provider#offers,#if#necessary#explain#that#this#is#for#a#positive#diagnosis)#

! 1!!=!Complete!pack!of!Malarine!or!A+M!or!Eurartesim!or!Duocotecxin!only#

! 2!!=!Complete!pack!of!Malarine!or!A+M!or!Eurartesim!or!Duocotecxin!and!tnam!psom!

! 3!!=!Tnam!psom!!only!

! 4!!=!!Other!(specify)#[____________________________________________________]#!

[___]!

!Go#to#Section#III:#Diagnostic#Audit!!Section"III:"Diagnostic"Audit"

!D1.#Do!patients!/!customers!need!to!register!to!use!this!facility?!

!

1!=!Yes,!Sometimes#2!=!Yes,!Always!3!=!No,!Never!!!!!!!!!!go#to#D3!#

[___]!

D2.!How!much!does!it!cost!for!an!adult!to!register!with!this!facility?!!

0000!=!Free!9997!=!Refused#

! 9998!=!Don’t!know!

![___![___|___|___|___]!Riel!

D3.#Is!malaria!microscopic!testing!available!here!today?!!

1!!=!!Yes!0!!=!!No! ! go#to#D7#!

[___]!

D4.!When!performing!malaria!microscopic!testing!is!the!slide!read!onsite!or!sent!away!to!be!read!elsewhere?!

!

1!!=!Onsite!0!!=!!Sent!away#

!

[___]!

D5.!How!many!microscopic!tests!of!malaria!did!you!conduct!over!the!past!7!days?!!

9998!=!Don’t!know!! [___|___|___|___]!

D6.! !! !! What!is!the!total!cost!for!a!microscopic!test!for!an!adult:!! [___|___|___|___|___]!Riel!!! Of!this!total,!what!is!the!cost!for!the!test!only:!! [___|___|___|___|___]!Riel!#! Of!this!total,!what!is!the!cost!for!consultation!and!other!fees:!! [___|___|___|___|___]!Riel"!

Record#1#for#all#responses#given#Record#0#for#responses#not#given#

Page 42: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 38!

Free#=#00000;#NA#=#99995;#Refused#=#99997;#Don’t#know=99998#!

D7.!Rapid!diagnostic!tests,!also!called!RDTs,!are!small,!individually!wrapped!blood!tests!that!are!able!

to!quickly!diagnose!whether!a!person!has!malaria.!Have!you!heard!of!RDTs?!

!

1!=!Yes! ! ! go#to#D9#0!=!No#8!=!Don’t!know#!

[___]!

D8.!Show#RDT#images#in#prompt#card####Say:#This#is#a#rapid#diagnostic#test#for#malaria.#Have#you#ever#seen#one#of#these#before#today?#

!

1!=!Yes! ! ! go#to#D9#0!=!No! ! ! go#to#D22:#Gloves#and#sharps#8!=!Don’t!know! ! go#to#D22:#Gloves#and#sharps#"

[___]!

D9.!Say:#I’d#like#to#ask#you#some#questions#about#how#reliable#you#think#RDTs#are.#When!an!RDT!is!positive!for!malaria,!how!likely!do!you!think!it!is!that!the!person!tested!actually!has!malaria?!Read#list.#Record#only#one#response.!

!

1!=!Certain!they!have!malaria#2!=!Very!likely!they!have!malaria!3!=!Somewhat!likely!they!have!malaria!4!=!Not!very!likely!they!have!malaria!5!=!Not!at!all!likely!they!have!malaria!

[___]!

D10.!When!an!RDT!is!negative!for!malaria,!how!likely!do!you!think!it!is!that!the!person!tested!actually!has!malaria?!Read#list.#Record#only#one#response.!

!

1!=!Certain!they!have!malaria#2!=!Very!likely!they!have!malaria!3!=!Somewhat!likely!they!have!malaria!4!=!Not!very!likely!they!have!malaria!5!=!Not!at!all!likely!they!have!malaria!

!

[___]!

D11.!Would!you!ever!recommend!a!patient/customer!take!an!antimalarial!if!they!tested!negative!for!malaria?!Read#list.#Record#only#one#response.!

!

1!=!Yes,!Sometimes#2!=!Yes,!Always!0!=!No,!Never! ! go#to#D13!8!=!Don’t!know! ! go#to#D13#

!

[___]!

D12.!Under!what!circumstances!would!you!recommend!a!patient/customer!take!an!antimalarial!following!a!negative!test!for!malaria?!Do#not#read#list.#Prompt#“anything#else”#once!

!

!!

I. ! When!they!have!signs/symptoms!of!malaria!

II. ! When!they!ask!for!antimalarial!treatment!

III. ! When!they!are!a!child!

IV. ! When!they!are!an!adult!

V. ! When!they!are!a!pregnant!woman!

VI. ! When!I!do!not!trust/believe!the!test!

VII. ! When!I!know!the!patient/customer!

VIII. Other!(specify)![___________________________]!

IX. Other!(specify)![___________________________]!!

!!!!

!!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

Record#1#for#all#responses#given#Record#0#for#responses#not#given#

Page 43: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 39!

D13.#Are!RDTs!available!here!today?!!

1!=!Yes!0!=!No! ! ! go#to#D16"8!=!Don’t!know! ! go#to#D16#"

[___]!

D14.#Do!you!offer!an!RDT!testing!service!in!this!outlet/facility?!!

1!=!Yes,!offer!testing!service!on!site#0!=!No,!only!sell!the!RDT#!

[___]!

D15.!Please!show!us!the!full!range!of!RDTs!that!you!currently!have!in!stock.!Do!you!currently!have!any!of!the!following?!Read#entire#list;#No#response#to#be#recorded.##

• Malacheck,)Paracheck,)Care)Start,)Para)Screen)!

!Proceed#to#the#RDT#audit.#

!If#additional#audit#sheets#are#used,#add#these#sheets#after#the#ones#provided#and#staple#the#questionnaire#again.#All#pages#should#be#in#order#before#you#move#onto#the#next#outlet.##Number#each#RDT#by#assigning#a#Product#Number.#Number#each#audit#sheet#used#in#the#spaces#provided#at#the#bottom#of#the#page.##In#health#facilities#complete#the#Dispensary#/#Clinic#Code#as#well#as#the#Product#Number#for#each#RDT#audited.#Dispensary#/#Clinic#codes#are#listed#below.!!!

#

!

Dispensary#/#Clinic#Codes!

A! Outpatient!department!/!dispensary!(if!used!by!all!patients)!

B! Adult!outpatient!department!/!adult!dispensary!/!adult!clinic!

C! Child!outpatient!department!/!child!dispensary!/!child!clinic!

D! Antenatal!/!maternity!clinic!

E! ART!/!HIV/AIDS!clinic!

G! Private!dispensing!unit!within!a!public!hospital!

L! Laboratory!(for#RDT#audit)#

Z! Comprehensive!Clinic!/!Other!(note#type#in#audit#comments)#

Page 44: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

RAPID DIAGNOSTIC TEST AUDIT SHEET (RDT) OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 40!

!

!

RDT!Audit!Sheet![___|___]!of![___|___]

Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

1.&Brand&name&(Include&the&terms&such&as&Pf,&Pv,&Pan&&if&visible&on&the&pack)&

2.&&Manufacturer&&

3.&&Country&of&Manufacture&&&&&!

4.&&Lot&Number! 5.&&Number&of&tests&sold/&distributed&/used&in&the&last&7&days&to&individual&consumers&(Record(total(#(of(tests)&This!outlet!sold!or!distributed!!!![___|___|___|___]!tests!in!the!last!7!days!!Refused!=!9997!;!Don’t!know!=!9998&

&!

[___|___|___]!6a.&Has&this&test&been&stocked&out&at&any&point&in&the&past&2&weeks?&!!

!!1!=!Yes!!!0!=!No!!!8!=!Don’t!know!!

!

!!!!!!!!!![___]!

6b.&Has&this&test&been&stocked&out&at&any&point&in&the&past&3&months?&!

1!=!Yes!0!=!No!8!=!Don’t!know!

!

!!!!![___]!

6c.&Has&this&test&been&stocked&out&for&at&least&one&week&at&any&point&in&the&past&3&months?&&

1!=!Yes!0!=!No!8!=!Don’t!know!

!

!!!!![___]&

7.&&Price&for&adults&What!is!the!total!cost!of!an!RDT!for!an!adult:! [___|___|___|___|___]!Riel!!

Of!this!total,!what!is!the!cost!for!the!test!kit!only:!!! [___|___|___|___|___]!Riel!!

Of!this!total,!what!is!the!cost!for!consultation!or! [___|___|___|___|___]!Riel!other!fees:! ! !!

8.&&Wholesale&purchase&price&For!!the!outlet’s!most!recent!wholesale!purchase:!![___|___|___|___]!tests!cost!!![___|___|___|___|___]!Riel&!

&

9.&&Comments&

Free!=!00000;!NA!=!99995;!Refused!=!99997;!Don’t!Know&

Clinic&code&&&[_____]!_______!&Product&number&&![__|__]!

1.&Brand&name&(Include&the&terms&such&as&Pf,&Pv,&Pan&&if&visible&on&the&pack)&

2.&&Manufacturer&&

3.&&Country&of&Manufacture&&&&&!

4.&&Lot&Number! 5.&&Number&of&tests&sold/&distributed&/used&in&the&last&7&days&to&individual&consumers&(Record(total(#(of(tests)&This!outlet!sold!or!distributed!!!![___|___|___|___]!tests!in!the!last!7!days!!Refused!=!9997!;!Don’t!know!=!9998&

&!

[___|___|___]!6a.&Has&this&test&been&stocked&out&at&any&point&in&the&past&2&weeks?&!!

!!1!=!Yes!!!0!=!No!!!8!=!Don’t!know!!

!

!!!!!!!!!![___]!

6b.&Has&this&test&been&stocked&out&at&any&point&in&the&past&3&months?&!

1!=!Yes!0!=!No!8!=!Don’t!know!

!

!!!!![___]!

6c.&Has&this&test&been&stocked&out&for&at&least&one&week&at&any&point&in&the&past&3&months?&&

1!=!Yes!0!=!No!8!=!Don’t!know!

!

!!!!![___]&

7.&&Price&for&adults&What!is!the!total!cost!of!an!RDT!for!an!adult:! [___|___|___|___|___]!Riel!!

Of!this!total,!what!is!the!cost!for!the!test!kit!only:!!! [___|___|___|___|___]!Riel!!

Of!this!total,!what!is!the!cost!for!consultation!or! [___|___|___|___|___]!Riel!other!fees:! ! !!

8.&&Wholesale&purchase&price&For!!the!outlet’s!most!recent!wholesale!purchase:!![___|___|___|___]!tests!cost!!![___|___|___|___|___]!Riel&!

&

9.&&Comments&

Free!=!00000;!NA!=!99995;!Refused!=!99997;!Don’t!Know&

Page 45: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 41!

!RDT!stock!outs!D16.!Are!there!any!malaria!RDTs!that!are!out!of!stock!today,!but!that!you!stocked!in!the!past!2"weeks?!!

1!=!Yes!0!=!No! ! go#to#D18#!8!=!Don’t!know! go#to#D18!

!

[___]!

D17.!Do!you!know!the!brand!names!of!the!malaria!RDTs!that!are!out!of!stock?!Record#one#brand#per#line.!!

1!=!Yes,!specify# 0!=!No"

[____________________________________________________________________________]!

[____________________________________________________________________________]!

[____________________________________________________________________________]!

[___]!

D18.!Are!there!any!malaria!RDTs!that!are!out!of!stock!today,!but!that!you!stocked!in!the!past!3"months?!!

1!=!Yes!0!=!No! ! go#to#D20!8!=!Don’t!know! go#to#D20!!

[___]!

D19.!Do!you!know!the!brand!names!of!the!malaria!RDTs!that!are!out!of!stock?!Record#one#brand#per#line.!!

1!=!Yes,!specify# 0!=!No"

[____________________________________________________________________________]!

[____________________________________________________________________________]!

[____________________________________________________________________________]!

[___]!

D20.!Have!the!following!RDTs!that!are!currently!out!of!stock!been!out!of!stock!for!1!week!or!longer!at!any!point!in!the!last!three!months?!!

#

RDTs#that#have#not#been#recorded#on#the#audit#sheets#are#currently#out#of#stock.###

I.!!!!!!!!!!!!!!!!CARESTART!MALARIA!

II.! ! !MALACHECK!

III.! !!!!!!!!!!FIRST!RESPONSE!!

1!=!Yes!0!=!No!8!=!Don’t!know!5!=!Not!applicable!!!!!!!

[___]!

[___]!

[___]!!

D21.!Did!the!last!patient!you!provided!an!antimalarial!to!also!receive!a!malaria!diagnostic!test!from!this!outlet?!! 1!!=!!Yes!! 0!!=!!No!! 99!!=!!Don’t!know!!

[___]!

!

Gloves!and!Sharps!D22.!Does!this!outlet/facility!have!disposable!gloves!available!today!for!staff!to!use!when!seeing!

customers/patients?!!

1!=!Yes!0!=!No!8!=!Don’t!know!

!

[___]!

D23.!Does!this!outlet/facility!have!a!sharps!container,!also!called!a!sharps!disposal!box!or!safety!box,!available!today!for!staff!to!use?!

!

1!=!Yes!0!=!No!8!=!Don’t!know!

!

[___]!

!Go#to#Section#IV:#Provider#Module!

Page 46: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 42!

Section"IV:"Provider"Module"!P1.!What!is!your!job!at!this!outlet/facility?.#

Do#not#read#list.!Prompt#“anything#else”#once#!

!!

I.! Pharmacist!

II.! Medical!doctor!

III.! Clinical!Officer!

VI.! Primary!Nurse!

V.! Secondary!Nurse!

VI.! Midwife!

VII.! Laboratory!technician!/!Lab!assistant!

VIII.! Pharmacy!technician!/!Pharmacy!assistant!

IX.! Health!assistant!/!Nursing!assistant!/!Nursing!aid!

X.! Village!Malaria!Worker!/!Mobile!Malaria!Worker!

XI.! Lab!technician!

XII.! Owner!

XIII.! Shop!assistant!

XIV.! Relative!of!owner!!

XV.! Other!(specify)##[_________________________]

!!!

!!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!!

![___]!!

P2.!For!how!many!years!have!you!worked!in!this!outlet/facility?!If"less"than"1"year,"enter"01![___|___]!yrs!

P3.!Including!yourself,!the!owner!and!support!staff,!how!many!people!work!at!this!outlet/facility?!If#outlet#has#multiple#dispensaries,#record#number#of#staff#at#this#dispensary#only!

!

98!=!Don’t!know!!

![___|___]!

P4.!Has!anybody!working!in!this!outlet/facility!completed!secondary!school?!!

1!=!Yes! ! go#to#P6#0!=!No!8!=!Don’t!know!

[___]!

P5.!Has!anybody!working!in!this!outlet/facility!completed!primary!school?!!

1!=!Yes#0!=!No!8!=!Don’t!know!

[___]!

P6.!Does!anyone!working!in!this!outlet/facility!have!a!health!related!qualification?!!

1!=!Yes#0!=!No! ! go#to#P8!8!=!Don’t!know! go#to#P8!

[___]!

Record#1#for#all#responses#given#Record#0#for#responses#not#given#

Page 47: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 43!

P7.!How!many!people!working!in!this!outlet/facility!including!yourself!and!the!owner!have!the!following!types!of!health!qualifications?!

# Read#list.!Enter#‘00’#if#answer#is#None.#Crosscheck#total#with#total#number#of#staff#recorded#in#P3#

I.! Pharmacist!

II.! Medical!doctor!

III.! Clinical!officer!

IV.! Nurse!/!Nursing!officer!

V.! Midwife!

VI.! Laboratory!technician!/!Lab!assistant!

VII.! Pharmacy!technician!/!Pharmacy!assistant!

XIII.! Health!assistant!/!Nursing!assistant!/!Nursing!aid!

IX.! Village!Malaria!Worker!/!Mobile!Malaria!Worker!

X.! Other!1:"specify![____________________________________]!

XI.! Other!2:!specify#[____________________________________]!

XII.! Other!3:!specify [____________________________________]!

!!

!!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

[___|___]!

P8.!In!the!past!12!months!has!anybody!working!in!this!outlet/facility!received!training!on!how!to!handle!a!case!of!fever.!Include#preSservice#training#and#standSalone#workshops.#

!

1!=!Yes#0!=!No!

! 8!=!Don’t!know!

[___]!

P9.!In!the!past!12!months!has!anybody!working!in!this!outlet/facility!received!training!on!how!to!handle!a!case!of!malaria?!Include#preSservice#training#and#standSalone#workshops.#

!!

1!=!Yes#0!=!No!

! 8!=!Don’t!know!

[___]!

## ### Interviewer:#Check!the!outlet!type!code!(C7)!on!page!1.!

If!C7!is!19!or!20!(this!outlet!only!offers!diagnostic!services)!skip#to#Section#V:#Audit#Tracking#Sheet.#!

P10.!Of!all!of!the!people!who!work!here,!how!many!prescribe!medicines?#Crosscheck#total#with#total#number#of#staff#recorded#in#P3#

! 98!=!Don’t!know!

![___|___]!

P11.!Of!all!of!the!people!who!work!here,!how!many!dispense!medicines?#Crosscheck#total#with#total#number#of#staff#recorded#in#P3#

! 98!=!Don’t!know!

![___|___]!

P12.!How!do!you!typically!decide!which!antimalarials!to!stock?#Read#list.#

!!!!

!

I.! Stock!most!profitable!antimalarials!

II.! Stock!antimalarials!recommended!by!the!government!

III.! Stock!the!lowest!priced!antimalarials!

IV.! Stock!according!to!customer!demand!

V.! Stock!based!on!brand!reputation!

VI.! Stock!antimalarials!that!are!prescribed!most!often!by!doctors!

VII.! Stock!the!most!effective!antimalarials!

VIII.Other:!specify#[______________________________________]!

IX.! Don’t!know!/!Respondent!not!responsible!for!buying!stock!

!!!!

!!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!!

!

Record#1#for#all#responses#given#Record#0#for#responses#not#given#

Page 48: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 44!

!Interviewer:##For!the!following!two!questions!record!the!antimalarial!brand!name!or!generic!name(s),!and!dosage!form,!in!the!spaces!provided.!Ask!the!provider!to!show!you!the!medicine!if!it!is!in!stock!to!verify!the!name!and!dosage!form.!!!P13.!In!your!opinion,!for!treating!uncomplicated!malaria!in!adults,!what!is!the!most!effective!antimalarial!medicine?!!

Generic"or"brand"name""

Dosage"form"01!=!Tablet!02!=!Suppository!03!=!Granule!

!04!=!Syrup!05!=!Suspension!06!=!Liquid!inj.!07!=!Powder!inj.!

!95!=!No!preference!96!=!Other!(specify)!98!=!Don’t!know!

![_________________________________________]!!

Don’t#know#=#98!

[___|___]!!

If#Other,#specify![__________________________________]!!

!

!!!P14.!What!antimalarial!medicine!for!treating!uncomplicated!malaria!in!adults!do!you!most!often!recommend!to!customers?!!

Generic"or"brand"name""

Dosage"form"01!=!Tablet!02!=!Suppository!03!=!Granule!

!04!=!Syrup!05!=!Suspension!06!=!Liquid!inj.!07!=!Powder!inj.!

!95!=!No!preference!96!=!Other!(specify)!98!=!Don’t!know!

![_________________________________________]!!

Don’t#know#=#98!

[___|___]!!

If#Other,#specify![__________________________________]!!

!

!!! !

Page 49: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 45!

!P15.!! Please!name!the!first!line!treatment!recommended!by!the!government!for!uncomplicated!

malaria!fever!in!adults.!

!

Do#not#read#list.#Only#one#response#allowed.!!

01=!DihydroartemisiningPiperaquine!(Duogcotecxin,!Eurartesim)!Only!.....................!go#to#P16!02=!Artesunate!Mefloquine!(Any!A+M,!Malarine,!Artequin)!Only...........................…!go#to#P17#03!=!ArtesunategMefloquine!(Any!A+M,!Malarine,!Artequin)!+!Primaquine!#04!=!DihydroartemisiningPiperaquine!(Duogcotecxin,!Eurartesim)!+!Primaquine!#05!=!Primaquine!Only#06!=!ArtemisiningPiperaquine!(Artequick)!!07!=!Amodiaquine!08!=!Artemether!09!=!Artemisinin!10!=!Artesunate!11!=!Chloroquine!12!=!Quinine!13!=!Sulfadoxine!Pyrimethamine!(Fansidar,!SP)!96!=!Other!specify:![___________________________________________]!98!=!Don’t!know!!

[___|___]!

Interviewer:## For!the!following!two!questions,!after!asking!the!initial!question,!prompt!the!provider!to!recall!details!about!the!

medicine!strengths,!the!total!number!of!tablets!taken!and!the!dosing!schedule/frequency!one!time!only.!!

! If!the!respondent!has!the!medicines!available!or!can!identify!the!medicines!from!the!prompt!card!then!use!the!available!packages!or!identified!medicine!to!verify!medicine!strengths.!

! If!identification!is!not!possible,!ask!respondent!to!recall!medicine!strength.!!

! Record#1#for#all#responses#given#and#record#0#for#all#responses#not#given# P16.!!Please!explain!the!government!recommended!strength,!number!of!tablets!and!dosing!schedule!for!

Dihydroartemisinin/Piperaquine!for!uncomplicated!malaria!fever!in!adults.!

!

! I.! Strength"...............................................................................!Dihydroartemisinin!=!40mg,!Piperaquine!=!320mg!

! II.! #"Tablets"..........................................................................................!Dihydroartemisinin/Piperquine!=!9!tablets!

! III.! Schedule"....................................................................!Dihydroartemisinin/Piperquine!=!3!tablets/day!for!3!days!!Skip#to#Question#P18!

!

!

[___]!

[___]!

[___]!

P17.!Please!explain!the!government!recommended!strength,!number!of!tablets!and!dosing!schedule!for!Artesunate,!

Mefloquine!for!uncomplicated!malaria!fever!in!adults.!

! I.!! Strength!............................................................................................!Artesunate!=!50mg,!Mefloquine!=!250mg!

! II.!! #"Tablets!..............................................................................................!Artesunate!=!12,!Mefloquine!=!5!tablets!

! III.! Schedule!................................!Artesunate,!Mefloquine:!Day!1!g!Artesunate!=!4!tablets,!Mefloquine!=!2!tablets#

! ! ! ! !!!! ! ! ! !!!!!!!Day!2!g!Artesunate!=!4!tablets,!Mefloquine!=!2!tablets!

! ! ! !!!! !!!! ! ! !!!!!!!Day!3!g!Artesunate!=!4!tablets,!Mefloquine!=!1!tablet!

!

!

[___]!

[___]!

!

!

[___]!

!

go#to#P18#

Page 50: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 46!

P18.!What!are!the!signs!and!symptoms!of!uncomplicated!malaria!in!an!adult?#Do#not#read#list.#Prompt#“anything#else”#once.#

!I. ! Trouble!breathing!/!abnormal!breathing! !

II. ! Chills!/!coldness!/!shivers!

III. ! Convulsions!

IV. ! Cough!/catarrh!

V. ! Dark!urine!/!blood!in!urine!

VI. ! Diarrhea!

VII. ! Excessive!sleep!/!difficult!to!wake!

VIII. ! Fever!/!high!temperature!/!hot!body!

IX. ! Floppy!/!unable!to!sit!up!

X. ! Headache!

XI. ! Loss!of!appetite!/!loss!of!weight!

XII. ! Muscle!pain!/!body!aches!and!pains!

XIII. ! Shock!/!low!blood!pressure! !

XIV. ! Unable!to!drink!/!unable!to!eat/feed!

XV. ! Unconscious!/!coma!

XVI. !!! !!!!!Vomiting!

XVII. Weakness!/!inactive!/!feel!dull!

XVIII. ! ! !!!!!!Yellow!eyes!/!jaundice!

XIX. ! Other!specify![__________________________]!

XX. ! Don’t!know!

!

!!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

[___]!

P19.!What!would!you!do!if!an!adult!was!brought!to!this!outlet!with!severe!malaria?!Do#not#read#list.#Only#one#response#allowed.#01!=!Seek!advice/help!from!someone!in!this!facility!

02!=!Treat!the!child!in!this!facility!03!=!Refer!to!a!health!facility!(clinic,!hospital)!with!or!without!treating!here!

04!=!Refer!to!a!non!health!facility!outlet!(not!a!clinic!or!hospital)!with!or!without!treating!here!05!=!Send!them!away/home!without!medicine!

06!=!Send!them!away/home!with!medicine!96!=!Other!specify:#[__________________________________________________________]!!

! !!!!98!=!Don’t!know!!

[___|___]!

P20.!In!the!past!month,!did!you!ever!cut!blister!packs!or!sell!partial!packs!of!antimalarials?!! 1!!=!!Yes!

! 0!!=!!No! ! go#to#P22!! 8!!=!!Don’t!know! go#to#P22!

[___]!

P21.!What!is!the!most!common!reason!why!you!cut!blisters!or!sell!partial!packs?!! Do#not#read#list.#One#response#only.#

! 1!!=!!Full!blister!or!pack!is!too!expensive!for!patient!!! 2!!=!!It!is!more!profitable!to!sell!partial!blister!or!pack!

! 3!!=!!Cut!or!partial!is!sufficient!/!Full!blister!or!pack!has!too!many!pills!! 4!!=!!I!have!small!/!insufficient!stock!

! 5!!=!!Makes!it!easier!for!the!patient!to!take!the!medicine!! 6!!=!!Other#(specify)!![____________________________________________________________]!! 8!!=!!Don’t!know!

[___]!

Record#1#for#all#responses#given#Record#0#for#responses#not#given#

Page 51: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 47!

P22.!Who!is!most!at!risk!of!malaria!in!Cambodia?!

! Don’t#read#answers.#Multiple#responses#allowed.#

I.! Forest!worker!

II.! Migrant!people/worker!

III.! Pregnant!woman!

IV.! Children!under!5!

V.!Other!(specify)![___________________________]!

![___]!

[___]!

[___]!

[___]!

[___]!

P23.!Have!you!heard!about!the!activities!to!stop!the!spread!of!antimalarial!drug!resistance!in!this!area!of!Cambodia?!

! One#response#only.#! 1!!=!!Yes!

! 0!!=!!No!! 8!!=!!Don’t!know!

[___]!

P24.!Are!some!antimalarial!drugs!banned!in!Cambodia?!

! One#response#only.#

! 1!!=!!Yes!! 0!!=!!No! ! go#to#P26#! 8!!=!!Don’t!know! go#to#P26!

[___]!

P25.!Do!you!know!the!names!of!the!antimalarial!drugs!that!are!banned!in!Cambodia?!

! Will#accept#generic#or#brand#names.#Record#one#medicine#per#line.#

1!!=!!Yes,!specify# 0!=!No"

! [_____________________________________]!!!![_____________________________________]!

!! [_____________________________________]!!!![_____________________________________]!!!!!!!

!!!!!!!!![_____________________________________]!!!![_____________________________________]!

[___]!

P26.!Interviewer:## Only#ask#this#question#if#this#is#a#private#outlet#/#facility.## If#this#is#a#public#health#facility#or#VMW,#continue#to#the#Audit#Sheet#Tracker!

! Do!you!have!a!license/temporary!license!to!sell!drugs?!

! 1!!=!!Yes!

! 0!!=!!No!!!!!! go#to#Section#V:#Audit#Sheet#Tracker#

[___]!

P27.!Can!I!see!the!license?!

! Interviewer#observe#the#license#and#record#response#based#on#observation.#

! 1!!=!!Yes,!license!physically!observed!

! 0!!=!!No,!license!not!physically!observed!

[___]!

!Complete#the#audit#sheet#tracker#on#the#next#page#then#follow#the#instructions#for#ending#the#interview.#

! !

Record#1#for#all#responses#given#Record#0#for#responses#not#given#

Page 52: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

OUTLET ID: [___|___]-[___|___]-[___|___|___]-[___|___|___]

! 48!

Section"V:"Audit"Tracking"Sheet"!

T1.!Total!number!of!Tablet,!Suppository!&!Granule!Products"audited![___|___]!

!

T2.!Total!number!of!NongTablet!Products"audited![___|___]!

!

T3.!Total!number!of!RDT!Products"audited![___|___]!

! Complete Section IX: Other Medicines; Complete Section X: Ending the Interview.

THANK THE PROVIDER FOR THEIR PARTICIPATION

Return to C9 and record the final status of the interview and time completed.!

! !

Page 53: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 49!

Annex"4:""Key"Informant"Interview"Guide"

Person"Interviewed"!

Name:!! ____________________________________________!!!!!!

Job!Title:!! ___________________________________________!!!!!!

Organisation:!! ____________________________________________!!!!!!!!

Date:!! ____________________________________________!!

!

Contextual"questions:""!1. Please!tell!me!about!any!roles!you!have!in!relation!to!malaria!control!in!Cambodia.!2. Have!any!important!malaria!control! interventions!been!implemented?!!(e.g.!roll!out!

of!ITNs,!change!in!diagnostics,!change!in!firstgline!drug,!house!spraying,!etc)! !By!the!Government?!!By!faithgbased!organizations!or!NGOs?!!By!the!private!sector?!

3. Have!any!important!malaria!control!interventions!been!stopped!or!interrupted?!4. Have! there! been! any! changes! to! the! amount! funding! received! from! international!

sources?!National!sources?!!5. Have! any! malariagrelated! issues! recently! been! highlighted! in! the! media?! (e.g.,!

concerns!over!drug!safety!or!efficacy)!6. Have!there!been!changes!in!the!availability!of!antimalarials!in!public!health!facilities?!

(eg.!Changes!to!the!antimalarials!that!they!stock,!widegspread!stockgouts,!or!the!end!of!stockgouts)!

7. Have!there!been!any!important!changes!to!the!functioning!of!the!government!health!system! (e.g.! changes! in! user! fees! for! health! services,! introduction! of! new! types! of!health!workers,!opening!of!new!facilities,!etc.)!

8. Have! there! been! any! important! changes! in! design! of! implementation! of!pharmaceutical! regulation?! (e.g.! change! in! prescription! only! status! of! certain!antimalarials,!ban!of!certain!products,!crack!downs!!on!illegal!outlets,!etc.)!

9. Have!there!been!any!important!weather!events!that!could!have!affected!the!malaria!disease!burden!or!malaria!treatment?!(e.g.,!floods,!droughts,!etc.)!

10. Have! there! been! any! important! economic! changes! that! could! have! affected! the!malaria! disease! burden! or! malaria! treatment?! (e.g.,! high! inflation,! increase! in!unemployment,!change!in!basic!food!prices,!major!change!in!exchange!rate,!etc.).!

11. Have!there!been!any!important!political!events!that!could!have!affected!the!malaria!disease!burden!or!malaria!treatment!(e.g.,!elections,!unrest)!

12. Can! you! think! of! any! other! events! which!might! have! affected! the!malaria! disease!burden,!malaria!treatment!seeking!or!the!provision!of!malaria!treatment!

13. What! are! some! of! the! major! developments! in! ensuring! access! to! antimalarial!medicines!in!both!public!and!private!sectors!in!Cambodia?!

Page 54: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 50!

14. What!are!some!challenges!in!ensuring!access!to!antimalarial!medicines!in!both!public!and!private!sectors!in!Cambodia?!!We! are! asking! these! questions! of! a! wide! range! of! key! informants,! including! [list#people#already#identified].!Is!there!anyone!else!who!you!think!it!would!be!important!for!me!to!interview?!

! !

Page 55: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 51!

Annex"5:"Selected"Communes""

The!98!selected!communes!for!the!main!sample!are!listed!below.!!

Province" Province"Code"

Administrative"District"

District"Code"

Commune" Commune"Code"

Urban"/"Rural"Urban=1""

Zone" 2010"Population"

Battambang! 2! Kamrieng! 212! Boeung!Reang! 21202! 2! 1! 10731!Battambang! 2! Kamrieng! 212! Ou!Da! 21203! 2! 1! 6813!Battambang! 2! Kamrieng! 212! Ta!Saen! 21205! 2! 1! 6496!Battambang! 2! Phnom!Proek! 211! Barang!Thleak! 21104! 2! 1! 5439!Battambang! 2! Phnom!Proek! 211! Chak!Krey! 21103! 2! 1! 19603!Battambang! 2! Phnom!Proek! 211! Ou!Rumduol! 21105! 2! 1! 6361!Battambang! 2! Phnom!Proek! 211! Pech!Chenda! 21102! 2! 1! 13620!Battambang! 2! Samlout! 209! Mean!Chey! 20906! 2! 1! 4285!Battambang! 2! Samlout! 209! Samlout! 20905! 2! 1! 6805!Battambang! 2! Samlout! 209! Ta!Taok! 20901! 2! 1! 2759!Battambang! 2! Sampov!Lun! 210! Sampov!Lun! 21001! 2! 1! 1822!Battambang! 2! Sampov!Lun! 210! Serei!Mean!

Chey!21005! 2! 1! 11901!

Kampot! 7! Chum!Kiri! 704! Chres! 70401! 2! 1! 7487!Kampot! 7! Chum!Kiri! 704! Snay!Anhchit! 70403! 2! 1! 5763!Kampot! 7! Chum!Kiri! 704! Srae!Knong! 70405! 2! 1! 6392!Kampot! 7! Chum!Kiri! 704! Trapeang!

Reang!70407! 2! 1! 6962!

Pailin! 24! Pailin! 2401! Sangkat!Pailin! 240101! 1! 1! 13179!Pailin! 24! Pailin! 2401! Tuol!Lvea! 240103! 2! 1! 6229!Pailin! 24! Sala!Krau! 2402! Stueng!Kach! 240203! 2! 1! 12433!Pailin! 24! Sala!Krau! 2402! Stueng!Trang! 240202! 2! 1! 9132!Pursat! 15! Veal!Veaeng! 1506! Pramaoy! 150604! 2! 1! 5740!Banteay!Meanchey!

1! Krong!Paoy!Paet! 110! Paoy!Paet! 11002! 1! 2! 76730!

Banteay!Meanchey!

1! Ou!Chrov! 105! Kuttasat! 10503! 2! 2! 6057!

Banteay!Meanchey!

1! Thma!Puok! 107! Kouk!Romiet! 10702! 2! 2! 19249!

Battambang! 2! Rotonak!Mondol!

207! Sdau! 20701! 2! 2! 17615!

Kampong!Speu!

5! Basedth! 501! Basedth! 50101! 2! 2! 12126!

Kampong!Speu!

5! Phnum!Sruoch! 506! Chambak! 50601! 2! 2! 3709!

Kampong!Speu!

5! Thpong! 508! Amleang! 50801! 2! 2! 10104!

Kampot! 7! Chhuk! 703! Trapeang!Phleang!

70309! 2! 2! 18929!

Kampot! 7! Kampot! 707! Koun!Satv! 70708! 2! 2! 8840!

Koh!Kong! 9! Kaoh!Kong! 903! Kaoh!Kapi! 90302! 2! 2! 3021!

Koh!Kong! 9! Srae!Ambel! 906! Srae!Ambel! 90606! 2! 2! 13569!

Oddar!Meanchey!

22! Banteay!Ampil! 2202! Kouk!Mon! 220204! 2! 2! 11124!

Page 56: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 52!

Oddar!Meanchey!

22! Samraong! 2204! Ou!Smach! 220405! 2! 2! 9654!

Preah!Vihear! 13! Chhaeb! 1302! Kampong!Sralau!Muoy!

130207! 2! 2! 2823!

Preah!Vihear! 13! Kuleaen! 1304! Phnum!Tbaeng!Pir!

130405! 2! 2! 3594!

Preah!Vihear! 13! Tbaeng!Mean!Chey!

1307! Preah!Khleang! 130706! 2! 2! 2557!

Pursat! 15! Krakor! 1503! Svay!Sa! 150310! 2! 2! 8317!Siem!Reap! 17! Angkor!Chum! 1701! Kouk!Doung! 170103! 2! 2! 14427!Siem!Reap! 17! Chi!Kraeng! 1704! Kampong!Kdei! 170403! 2! 2! 12280!Siem!Reap! 17! Soutr!Nikom! 1711! Chan!Sar! 171101! 2! 2! 9112!Siem!Reap! 17! Srei!Snam! 1712! Prei! 171205! 2! 2! 3984!Sihanoukville! 18! Kampong!Seila! 1804! Kampong!Seila! 180402! 2! 2! 6574!Kampong!Cham!

3! Chamkar!Leu! 302! Spueu! 30205! 2! 3! 17029!

Kampong!Cham!

3! Dambae! 304! Tuek!Chrov! 30406! 2! 3! 15372!

Kampong!Cham!

3! Memot! 310! Memot! 31008! 2! 3! 15098!

Kampong!Cham!

3! Ponhea!Kraek! 312! Veal!Mlu! 31209! 2! 3! 7549!

Kampong!Cham!

3! Stueng!Trang! 315! Tuol!Sambuor! 31514! 2! 3! 4092!

Kampong!Chhnang!

4! Sameakki!Mean!Chey!

407! Krang!Lvea! 40703! 2! 3! 9181!

Kampong!Thom!

6! Kampong!Svay! 602! Trapeang!Ruessei!

60209! 2! 3! 17418!

Kampong!Thom!

6! Sandan! 606! Sandan! 60607! 2! 3! 9255!

Kratie! 10! Chhloung! 1001! Preaek!Saman! 100108! 2! 3! 9221!Kratie! 10! Sambour! 1004! Ou!Krieng! 100405! 2! 3! 5892!Mondul!Kiri! 11! Saen!

Monourom!1105! Romonea! 110504! 2! 3! 2640!

Ratanak!Kiri! 16! Ta!Veaeng! 1608! Ta!Veaeng!Leu! 160801! 2! 3! 3632!Sihanoukville! 18! Prey!Nob! 1802! Tuol!Totueng! 180213! 2! 3! 4342!Takeo! 21! Tram!Kak! 2109! Ou!Saray! 210906! 2! 3! 13613!Banteay!Meanchey!

1! Mongkol!Borei! 102! Rohat!Tuek! 10208! 2! No Zone 12604!

Banteay!Meanchey!

1! Phnum!Srok! 103! Srah!Chik! 10305! 2! No Zone 6869!

Banteay!Meanchey!

1! Serei!Saophoan! 106! OU!Ambel! 10605! 1! No Zone 16742!

Battambang! 2! Aek!Phnum! 205! Preaek!Luong! 20504! 2! No Zone 9988!Battambang! 2! Bat!Dambang! 203! Kdol!Daun!

Teav!20306! 1! No Zone 9359!

Battambang! 2! Bavel! 204! Bavel! 20401! 2! No Zone 26182!Battambang! 2! Moung!Ruessei! 206! Prey!Touch! 20608! 2! No Zone 11314!Battambang! 2! Sangkae! 208! Vaot!Ta!

Moem!20810! 2! No Zone 14808!

Kampong!Cham!

3! Batheay! 301! Chealea! 30103! 2! No Zone 7455!

Page 57: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 53!

Kampong!Cham!

3! Cheung!Prey! 303! Sdaeung!Chey! 30307! 2! No Zone 11022!

Kampong!Cham!

3! Kampong!Siem! 306! Krala! 30609! 2! No Zone 10177!

Kampong!Cham!

3! Kang!Meas! 307! Sdau! 30710! 2! No Zone 6225!

Kampong!Cham!

3! Krouch!Chhmar! 309! Roka!Khnaor! 30909! 2! No Zone 12373!

Kampong!Cham!

3! Ponhea!Kraek! 312! Kandaol!Chrum!

31204! 2! No Zone 19987!

Kampong!Cham!

3! Prey!Chhor! 313! Tong!Rong! 31314! 2! No Zone 6799!

Kampong!Cham!

3! Tboung!Khmum! 316! Boeng!Pruol! 31602! 2! No Zone 7845!

Kampong!Chhnang!

4! Chol!Kiri! 402! Kaoh!Thkov! 40202! 2! No Zone 9365!

Kampong!Chhnang!

4! Kampong!Tralach!

405! Peani! 40507! 2! No Zone 7727!

Kampong!Chhnang!

4! Sameakki!Mean!Chey!

407! Tbaeng!Khpos! 40708! 2! No Zone 9504!

Kampong!Speu!

5! Chbar!Mon! 502! Roka!Thum! 50203! 1! No Zone 15522!

Kampong!Speu!

5! Odongk! 505! Cheung!Roas! 50502! 2! No Zone 7339!

Kampong!Speu!

5! Samraong!Tong! 507! Krang!Ampil! 50704! 2! No Zone 8644!

Kampong!Thom!

6! Baray! 601! Ballangk! 60102! 2! No Zone 16310!

Kampong!Thom!

6! Kampong!Svay! 602! Chey! 60201! 2! No Zone 5190!

Kampong!Thom!

6! Stoung! 608! Kampong!Chen!Tboung!

60805! 2! No Zone 9831!

Kampot! 7! Angkor!Chey! 701! Phnum!Kong! 70108! 2! No Zone 11015!Kampot! 7! Chhuk! 703! Krang!Sbov! 70306! 2! No Zone 5512!Kampot! 7! Kampong!Trach! 706! Kampong!

Trach!Khang!Kaeut!

70605! 1! No Zone 11093!

Kratie! 10! Preaek!Prasab! 1003! Kampong!Kor! 100303! 2! No Zone 6197!Pursat! 15! Kandieng! 1502! Kanhchor! 150204! 2! No Zone 7559!Pursat! 15! Sampov!Meas! 1505! Svay!At! 150507! 2! No Zone 4902!Siem!Reap! 17! Kralanh! 1706! Krouch!Kor! 170604! 2! No Zone 4935!Siem!Reap! 17! Puok! 1707! Mukh!Paen! 170708! 2! No Zone 5438!Siem!Reap! 17! Siem!Reab! 1710! Sala!Kamraeuk! 171004! 1! No Zone 23043!Siem!Reap! 17! Soutr!Nikom! 1711! Kampong!

Khleang!171104! 2! No Zone 10849!

Takeo! 21! Bati! 2102! Doung! 210203! 2! No Zone 10860!Takeo! 21! Borei!Cholsar! 2103! Kouk!Pou! 210305! 2! No Zone 10390!Takeo! 21! Kiri!Vong! 2104! Phnum!Den! 210407! 2! No Zone 7818!Takeo! 21! Prey!Kabbas! 2106! Snao! 210612! 2! No Zone 6453!Takeo! 21! Tram!Kak! 2109! Ang!Ta!Saom! 210901! 2! No Zone 15705!Takeo! 21! Treang! 2110! Prambei!Mom! 211005! 2! No Zone 9312!

""

Page 58: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 54!

Annex%6:%Definitions%of%Outlet%Types!!

Outlet%Types% Description%Public!Health!Facility Referral!Hospital! A!secondary!health!care!facility.!Hospitals!that!provide!health!services!to!people!in!their!coverage!area!through!

complementary!packaged!activities!(CPA).!Medical!consultation,!diagnostic!testing,!and!prescription!medicines!are!available.!Referral!hospitals!operate!at!the!district!level.!

Health!Center! A!primary!health!care!facility.!CommuneDlevel!health!facility!which!provides!health!services!to!people!in!their!coverage!area!with!minimum!packaged!activities!(e.g.!prescription!medicine!and!diagnosis)

Former!District!Hospital! A!primary!health!care!facility!that!was!formerly!a!district!hospital!but!is!now!functioning!as!a!health!centre,!but!may!be!better!equipped!and!provide!more!services!than!a!typical!health!centre.

Health!Post! A!primary!health!care!facility.!A!communeDlevel!health!facility!that!provides!services!to!complement!health!centre!activities!for!people!in!the!coverage!area!of!the!health!centre,!but!who!are!not!able!to!access!the!health!centre.!It!provides!health!services!of!minimum!packaged!activities.

Village!Malaria!Worker! A!volunteer!selected!by!villagers,!officially!recognized!and!trained!by!CNM!to!provide!malaria!diagnosis!and!ACT!treatment!at!their!village!with!monitoring!and!supervision!by!CNM.

Mobile!Malaria!Worker! Mobile!Malaria!Workers!are!Village!Malaria!Workers!that!aren't!based!within!a!village.!They!move!from!village!to!village!providing!diagnostic!and!treatment!service!to!people!in!their!assigned!areas.!

Pharmacy!Clinic!Private!Hospital/Clinic A!privately!owned!health!facility!that!offers!treatment!and!diagnosis!for!a!range!of!illnesses!at!a!commercial!rate.!All!

private!hospitals!and!clinics!must!be!licensed!by!the!MOH!and!are!staffed!by!qualified!health!practitioners Clinical!Pharmacy/Pharmacy !

These!are!legal!outlets!selling!a!wide!variety!of!medicines.!They!are!licensed!under!the!name!of!a!trained!pharmacist.!Most!pharmacies!are!located!in!Phnom!Penh.!They!receive!their!drug!supply!from!company!representatives!who!distribute!directly!to!most!provincial!capitals!and!district!towns.!They!provide!diagnostic!testing,!treatment,!and!prescription!medicines!to!patients.!Clinical!pharmacies!are!licensed!by!MOH!and!identified!by!a!pharmacy!signboard!with!the!provider’s!name.

Depot!A !

Depots!are!licensed,!legal,!outlets!registered!under!the!name!of!a!pharmacist!of!medical!assistant.!Depot!A!is!permitted!to!sell!60!kinds!of!essential!drugs.!Pharmacy!depots!are!located!in!urban!areas!like!provincial!or!district!towns.

Page 59: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 55!

Depot!B Depots!are!licensed,!legal,!outlets!registered!under!the!name!of!a!pharmacist!of!medical!assistant.!Depot!B!is!permitted!to!sell!20!kinds!of!essential!drugs.!Pharmacy!depots!are!located!in!urban!areas!like!provincial!or!district!towns.

Cabinet! These!are!divided!into!“legal”!clinics,!including!all!licensed!medical!providers!who!display!the!blue!medical!cross!indicating!to!the!public!the!presence!of!a!qualified!medical!person,!and!“illegal”!clinics!operated!by!unlicensed!private!providers.!The!legal!clinic!is!registered!under!a!licensed!medical!doctor!who!does!not!have!another!job.!The!license!for!operating!the!clinic!is!obtained!from!the!MOH.!The!illegal!clinics,!which!form!the!majority!of!private!medical!practices!in!the!country,!are!operated!by!unlicensed!practitioners!or!the!clinic!itself!is!not!registered!at!the!MOH.!This!category!includes!polyclinics,!clinics,!and!consultation!rooms.

NGO/Mission!Hospital NotDforDprofit!health!facilities!which!work!closely!with!provincial!health!departments.!These!facilities!provide!diagnosis!and!treatment!of!a!range!of!illnesses!at!a!reduced!or!no!cost.

Drug!Store!Drug!Store !

Drugs!stores!display!the!green!pharmacy!cross!(which!indicates!to!the!public!the!presence!of!a!qualified!pharmacist!or!drug!seller)!without!having!a!license.!This!category!includes!drug!stalls!in!rural!markets!and!shops!whose!main!business!is!selling!medicines.!Some!drug!vendors!may!buy!their!supply!from!legal!pharmacies!or!pharmacy!depots.!Drug!stores!are!smaller!than!pharmacies.

Mobile!Provider!Mobile!Provider! Found!mostly!in!rural!areas,!mobile!providers!travel!by!motorbike.!They!typically!work!within!a!radius!of!their!home!or!a!

base!venue.!They!are!not!registered,!hence!are!identified!by!asking!the!village!chief!of!mobile!providers!that!may!reside!or!work!within!the!community.!They!provide!medical!treatment!and!diagnosis,!and!also!sell!antimalarial!drugs!and!other!medicines!to!individuals!and!stores.

Retail!Outlet!Grocery!Store! Grocery!stores!are!usually!small!homeDbased!businesses!whereby!the!front!of!the!house!is!used!to!sell!goods,!including!

food,!beverages,!household!items,!and!some!health!products.

Village!Shop!Village!Shop! Village!shops!are!smaller!than!grocery!stores,!and!sell!a!limited!range!of!goods.!They!include!food/drink,!household!items,!

and!some!health!products.

Diagnostic!Lab!Diagnostic!Lab! Private!facilities!that!offer!onDsite!diagnostic!services.!Diagnostic!labs!may!or!may!not!distribute!or!sell!other!commodities!

including!medicines,!medical!equipment,!food!and!household!supplies.!!

Page 60: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 56!

Annex%7:%%Information%Sheet%&%Consent%Form%for%Outlet%Survey%

INFORMATION%SHEET%

Study%Title:%ACTwatch%Cambodia%Outlet%Survey%2013%

!(To!be!read!to!the!interviewee)!

%Why%are%we%conducting%this%research?%We!work! for! PSI! Cambodia.!We! are! conducting! a! study! to! determine! the! availability! of!antimalarials!and!RDTs.!The!results!will!be!used!to!improve!the!availability!of!appropriate!medicines!and!diagnostics!for!malaria!in!Cambodia.!!We!hope!to!hold!discussions!with!you.!We! feel! that! your! experience! providing! antimalarial! medicines! to! the! community! can!contribute! much! to! our! understanding! and! knowledge! of! how! we! can! improve! malaria!treatment.!!!I!would!like!to!ask!you!a!number!of!questions!about:!• The!type!of!medicines!and!RDTs!you!stock!and!their!prices!• If!you!have!had!any!recent!stock!outs!• The!characteristics!of!the!people!who!work!here!!• Your!registration!status!!In!addition,!I!would!like!to!ask!your!permission!to!see!the!antimalarial!medicines!and!RDTs!available!in!this!outlet.!%%How%long%will%the%interview%take?%The!interview!with!you!should!take!approximately!30!minutes!depending!on!the!number!of!antimalarials!you!have!in!stock.!!!Are%there%any%disadvantages%or%advantages%involved%in%taking%part?!There!are!no!individual!benefits!to!taking!part,!but!in!answering!our!questions!you!will!help!us!improve!our!understanding!of!how!to!increase!the!availability!of!malaria!treatment!for!the! benefit! of! everyone! living! in! Cambodia.! ! Unfortunately,! we! are! not! in! a! position! to!assist!with!financial!or!other!problems!that!we!come!across,!nor!can!we!provide!stock!for!your!shop/facility!or!buy!any!drug!from!your!shop/facility.!!!However,!we!hope!that!you!will!participate!since!your!views!are! important! for! the!study!and!the!results!from!the!study!will!improve!the!availability!of!antimalarials.!%

% %

Page 61: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 57!

Who%will%have%access%to%the%information%I%give?%We!are!not!here!to!inspect!your!business!and!no!information!about!this!specific!outlet!will!be!passed!on!to!the!regulatory!authorities.!We!will!not!share!individual!information!about!you!or!other!participants!with!anyone!beyond!our!research!team.!Instead,!the!knowledge!gained! from!this! research!will!be! shared! in! summary! form,!without! revealing! individuals’!identities!with!organizations!or!individuals!that!will!find!the!information!useful!in!improving!availability!of!malarial!treatment.!!%What%will%happen%if%I%refuse%to%participate?%%Participation!in!this!study!is!voluntary.! !You!are!free!to!decide!if!you!want!to!take!part!or!not.!!If!you!do!agree,!you!can!change!your!mind!at!any!time.!You!can!refuse!to!answer!any!specific!questions,!or!stop!the!interview!at!any!time.!If!you!chose!not!to!answer!a!question,!stop!the!interview!or!even!not!participate!at!all!in!the!study,!it!will!not!affect!your!working!conditions!today!or!in!the!future.!!!%What%if%I%have%any%questions?%If!you!have!any!questions,!you!can!ask!them!now!or!later.!If!you!wish!to!ask!questions!later,!you!may!contact!any!of!the!following:!!!Sochea!Phok!Country!Project!Coordinator,!PSI!Cambodia!Tel:!!017!562!568!!!Ms.!Phou!Mean!Research!Coordinator,!PSI!Cambodia!Tel:!012!753!995!!

Page 62: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 58!

CONSENT%FORM%%

Study%Title:%ACTwatch%Cambodia%Outlet%Survey%2013%!Lead%Investigator:%!Sochea!Phok!Country!Project!Coordinator,!PSI!Cambodia!!Oral! consent! is! required! for! all! interviews! and! should!be!witnessed!by! a!member!of! the!research!team.!!I!certify!that!I!have!followed!the!information!sheet!to!explain!this!study!to!the!participant,!from!___________________________________!(outlet!name),!and!that!s/he!understands!the!nature!and!the!purpose!of!the!study!and!consents!to!participate!in!the!study.!S/he!has!been!given!an!opportunity!to!ask!questions!which!have!been!answered!satisfactorily.!%� %please!tick!!!The%interviewee%agrees%to%be%interviewed%!!_____________________________! ! ______________________!!%_____________________________! ! ______________________!%Name%(please%print)% % % % Date%%%

THE%PROVIDER%SHOULD%NOW%BE%GIVEN%AN%INFORMATION%SHEET%TO%KEEP%%! !

Page 63: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 59!

Annex%8:%%Information%Sheet%&%Consent%Form%for%Key%Informants%

INFORMATION%SHEET%%

Study%Title:%ACTwatch%Cambodia%Key%Informant%Interviews%2013%!(To!be!read!to/!read!by!the!interviewee)!%Why%are%we%conducting%this%research?%We!work! for! PSI! Cambodia.! At! present,!we! are! conducting! a! survey! of! outlets! providing!antimalarials.!As!part!of!this!evaluation,!it!is!important!for!us!to!understand!the!context!of!malaria!patterns!and!treatment! in!Cambodia.!That! is,!we’d! like!to!know!more!about! ! the!factors!which!may!affect!treatment!received.!These!may!include!any!other!malaria!control!activities,! other! important! developments! in! the! health! sector,! or! more! general! social,!economic!or!political!events!which!could!affect!the!malaria!burden!or!malaria!treatment.!We!hope!to!hold!a!short!discussion!with!you!on!these!issues.!We!will!also!be!interviewing!other! individuals!who! are! knowledgeable! in! this! area,! including!Government! staff,! those!from! NGOs! and! faith]based! organizations,! and! those! from! UN! agencies! and! other!international!agencies!!!How%long%will%the%interview%take?%The!interview!with!you!should!take!approximately!30!minutes!!!Are%there%any%disadvantages%or%advantages%involved%in%taking%part?!There!are!no!individual!benefits!to!taking!part,!but!in!answering!our!questions!you!will!help!us! improve! our! understanding! of! how! to! increase! the! availability! of! effective! malaria!treatment!for!the!benefit!of!everyone!living!in!Cambodia.!!Who%will%have%access%to%the%information%I%give?%The!information!will!be!used!for!research!purposes!only.!No!one!other!than!the!research!team!will!be!allowed!to!see!the!record!of!the!interview.!We!will!not!disclose!your!identity,!or!use!your!name!in!any!reports!of!this!work.!!%What%will%happen%if%I%refuse%to%participate?%%Participation!in!this!study!is!voluntary.! !You!are!free!to!decide!if!you!want!to!take!part!or!not.!!If!you!do!agree,!you!can!change!your!mind!at!any!time.!You!can!refuse!to!answer!any!specific!questions,!or!stop!the!interview!at!any!time.!If!you!chose!not!to!answer!a!question,!stop!the!interview!or!even!not!participate!at!all!in!the!study!there!will!not!be!any!adverse!consequences!for!you!or!your!organisation.!!!%

Page 64: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 60!

What%if%I%have%any%questions?%If!you!have!any!questions,!you!can!ask!them!now!or!later.!If!you!wish!to!ask!questions!later,!you!may!contact!any!of!the!following:!!!Sochea!Phok!Country!Project!Coordinator,!PSI!Cambodia!Tel:!!017!562!568!!!!Mrs.!Phou!Mean!Research!Coordinator,!PSI!Cambodia!Tel:!012!753!995! !

Page 65: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 61!

CONSENT%FORM%%%

Study%Title:%ACTwatch%Cambodia%Key%Informant%Interviews%2013%!Lead%Investigator:%!Sochea!Phok!Country!Project!Coordinator,!PSI!Cambodia!!Oral! consent! is! required! for! all! interviews! and! should!be!witnessed!by! a!member!of! the!research!team.!%I! certify! that! I! have! followed! the! information! sheet! to! explain! this! study! to!__________________________________!(name!of!participant),!and!that!s/he!understands!the!nature!and!the!purpose!of!the!study!and!consent!to!the!participation!in!the!study.!S/he!has!been!given!an!opportunity!to!ask!questions!which!have!been!answered!satisfactorily.!%� %please!tick!!!The%interviewee%agrees%to%be%interviewed%!!_____________________________! ! ______________________!!%_____________________________! ! ______________________!%Name%(please%print)% % % % Date%!!

%THE%PARTICIPANT%SHOULD%NOW%BE%GIVEN%AN%INFORMATION%SHEET%TO%KEEP%%

!

Page 66: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 62!

References%_________________________ %

1.! United!States!Census!Bureau!(2013).!International!Data!Base!2013.!Accessed!July!17,!2013,!

http://www.census.gov/population/international/data/idb/informationGateway.php!

2.! Central!Intelligence!Agency!(2013).!The!World!Factbook:!Cambodia.!Accessed!July!17,!2013,!https://www.cia.gov/library/publications/the]!world]factbook/geos/cb.html!

3.! Cambodia!National!Institute!of!Statistics!(2008).!General!Population!Census!of!Cambodia!2008:!National!Report!on!Final!Census!Results.!Phnom!Penh,!Cambodia.!

4.! Grundy!J,!et!al.!(2009).!Health!system!strengthening!in!Cambodia:!a!case!study!of!health!policy!response!to!social!transition.!Health!Policy,!92!(2]3),!pp.!107]115.!

5.! Cambodia!National!Institute!of!Public!Health,!Cambodia!National!Institute!of!Statistics!and!ORC!Macro!(2010).!Cambodia!Demographic!and!Health!Survey!2010.!Phnom!Penh,!Cambodia.!

6.! Bigdeli!M,!Annear!L!(2009).!Barriers!to!access!and!the!purchasing!function!of!health!equity!funds:!lessons!from!Cambodia.!Bull!World!Health!Organ,!87!(7),!pp.!560]564.!

7.! Cambodia!Ministry!of!Planning,!World!Bank!(1999).!Cambodia!Poverty!Assessment.!Phnom!Penh,!Cambodia.!

8.! Yeung!S,!et!al.!(2008).!Access!to!artemisinin!combination!therapy!for!malaria!in!remote!areas!of!Cambodia.!Malar!J,!7,!p.!96.!

9.! Moszynski!P!(2010).!Cambodia!cracks!down!on!illegal!drug!vendors!in!bid!to!counter!antimalarial!resistance.!BMJ,!340,!p.!2622.!

10.!World!Health!Organization!(2013).!World!Malaria!Report!2012.!WHO!Press,!Geneva,!Switzerland.!

11.!World!Health!Organization!(2008).!Malaria!epidemiology,!Cambodia.!Accessed!July!15,!2008,!http://www.wpro.who.int/sites/mvp/epidemiology/malaria/cam_profile.htm.!

12.!Cambodia!National!Centre!for!Parasitology,!Entomology!and!Malaria!Control!(CNM),!Malaria!Consortium!(2011).!Cambodia!Malaria!Survey.!Phnom!Penh,!Cambodia.!

13.!Cambodia!National!Centre!for!Parasitology,!Entomology!and!Malaria!Control!(CNM)!(2010).!Annual!progress!Report!of!the!National!Malaria!Control!Programme.!Phnom!Penh,!Cambodia.!

14.!Jambou!R,!et!al.!(2005).!Resistance!of!Plasmodium!falciparum!field!isolates!to!in]vitro!artemether!and!point!mutations!of!the!SERCA]type!P.!falciparum!ATPase6.!Lancet,!266,!pp.!1960]1963.!

15.!Alker!AP,!Lim!P,!Sem!R,!et!al.!(2007).!Plasmodium!falciparum!mdr1!and!in!vivo!resistance!to!artesunate]mefloquine!in!falciparum!malaria!on!the!Cambodian]Thai!border.!Am!J!Trop!Med!Hyg,!76,!pp.!641]647.!

16.!Denis!MB,!Tsuyuoka!R,!Poravuth!Y,!et!al.!(2006).!Surveillance!of!the!efficacy!of!artesunate!and!mefloquine!combination!for!the!treatment!of!uncomplicated!falciparum!malaria!in!Cambodia.!Trop!Med!Int!Health,!11,!pp.!1360]1366.!

17.!Denis!MB,!Tsuyuoka!R,!Lim!P,!et!al.!(2006).!Efficacy!of!artemether]lumefantrine!for!the!treatment!of!uncomplicated!falciparum!malaria!in!northwest!Cambodia.!Trop!Med!Int!Health,!11!pp.1800]1807.!

18.!Noedl!H,!Se!Y,!Schaecher!K,!Smith!BL,!Socheat!D,!Fukuda!MM!(2008).!Evidence!of!artemisinin]resistant!malaria!in!western!Cambodia.!N!Engl!J!Med,!359,!pp.!2619]2620.!

19.!World!Health!Organization!(2012).!Battling!malaria!drug!resistance!along!the!Thai]Cambodian!border.!Accessed,!January!9,!2012,!http://www.who.int/malaria/diagnosis_treatment/arcp/containment_project/en/index.html!

Page 67: Cambodia study design 20131030 - ACTwatch...! 4! Figure!1:!Map!of!Cambodia!!!!! Source:!,!2013! The!importance!of!the!private!commercial!sector!is!relatively!recent.!From!1975!to!1979,!

! 63!

20.!Yasuoka!J,!et!al.!(2012).!Scale]up!of!community]based!malaria!control!can!be!achieved!without!degrading!community!health!workers'!service!quality:!the!Village!Malaria!Worker!project!in!Cambodia.!Malaria!J,!9,!p.109.!

21.!Dondorp,!AM,!et!al.!(2004).!Fake!antimalarials!in!Southeast!Asia!are!a!major!impediment!to!malaria!control:!multinational!cross]sectional!survey!on!the!prevalence!of!fake!antimalarials.!Tropical!Medicine!&!International!Health,!9.!pp.1241–1246.!

22.!World!Health!Organization!(2007).!Containment!of!Malaria!Multi]Drug!Resistance!on!the!Cambodia]Thailand!Border:!report!of!an!informal!consultation.!Accessed!January!19,!2012,!http://www.who.int/malaria/publications/multi_drug_resistance_en.pdf.!

23.!Letter!from!the!Ministry!of!Health!(2008).!

24.!Va!S!(2010).!Important!regulatory!steps!being!taken!in!Cambodia!to!phase!out!oral!artemisinin]based!monotherapies.!Presentation!at!the!14th!ICDRA,!3!December!2010,!Singapore.!Accessed!January!19,!2012,!http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/PL6]3.pdf!

25.!USAID!Cambodia!(2012).!Health!System!Strengthening.!Accessed!January!10,!2012,!http://cambodia.usaidallnet.gov/node/154.!Accessed!10!January!2012.!

26.!ACTwatch!Group!and!PSI!Cambodia!(2011).!ACTwatch!Household!Survey!Report.!Population!Services!International,!Washington,!DC.!

27.!ACTwatch!Group!and!PSI!Cambodia!(2011).!ACTwatch!Outlet!Survey!Report.!Population!Services!International,!Washington,!DC.!